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Acne, a highly prevalent skin disease, can be particularly bothersome for patients of Asian background because of its impact on self-confidence and social interactions. In addition to active acne lesions, some patients may develop sequelae such as scarring, macular/postinflammatory hyperpigmentation, or erythema. The tendency of Asian skin to develop sequelae because of its increased susceptibility to irritation, cultural preferences for lighter skin phototypes, and differences in skincare regimens may all contribute to the increased burden of acne. Moreover, many Asia-Pacific countries do not have their own guidelines for acne management, and those that do often have no schedule in place for regular updates. In this article, we provide a critical review of the published guidance for the management of acne and its sequelae in the Asia-Pacific region, identifying gaps in current recommendations that could be addressed to enhance standards of acne care in Asia-Pacific countries. Along with highlighting the importance of a comprehensive skincare regimen to increase treatment efficacy and adherence, we discuss topical retinoids and retinoid combination options in the acne armamentarium that may be beneficial for sequelae prevention and management, such as adapalene 0.3% ± benzoyl peroxide 2.5%, tretinoin 0.05%, tazarotene 0.1%, and trifarotene 0.005%. In particular, trifarotene 0.005% has been observed to significantly reduce acne scar counts in a Phase 4 study. The recent data highlight the need to establish up-to-date guidance for acne and acne sequelae management in Asia-Pacific countries to provide optimal care to Asian patients., (© 2024 Galderma and The Authors. International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.)

Background: Acne-induced hyperpigmentation (AIH) may accompany acne vulgaris (AV) inflammation in all skin phototypes. Trifarotene has shown depigmenting properties in vivo. This study evaluated trifarotene plus skincare because it is increasingly recognized that holistic AV management should include skincare and treatments., Methods: This is a phase IV double-blind, parallel-group study of patients (13-35 years) with moderate AV and AIH treated with trifarotene (N = 60) or vehicle (N = 63) plus skincare regimen (moisturizer, cleanser, and sunscreen) for 24 weeks. Assessments included the AIH overall disease severity (ODS) score, post-AV hyperpigmentation index (PAHPI), exit interviews, photography, and acne assessments. Standard safety assessments were included., Results: Trifarotene 50 μg/g cream improved significantly from baseline in ODS score versus vehicle (-1.6 vs. -1.1, P = 0.03) at Week 12, but scores were comparable between groups at Week 24 (primary endpoint). Trifarotene had a better reduction in PAHPI score at Week 24 (-18.9% vs. -11.3% vehicle, P < 0.01). Lesion count reductions were higher with trifarotene at Week 12 versus vehicle (P < 0.001) and at Week 24 (P < 0.05), as were IGA success rates versus vehicle at Weeks 12 (P < 0.05) and 24 (P < 0.05). Patients agreed that the skincare regimen contributed to less irritation, making treatment adherence easier. Photography showed improvements in pigmentation and erythema across all skin types. AEs were more common in the vehicle group versus trifarotene (30.2 vs. 16.7%, respectively)., Conclusions: In all skin phototypes, there was more rapid improvement in the ODS and PAHPI scores with trifarotene by Weeks 12 and 24, respectively. The combination of trifarotene and skincare correlated with high patient satisfaction and adherence to the treatment protocol., (© 2024 The Authors. International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.)

Background: Prurigo nodularis (PN) is a rare chronic inflammatory skin disease with a high disease burden, but data on clinical and economic burden are still scarce., Objective: To describe the real-world epidemiologic, clinical and therapeutic characteristics and related economic burden of patients with PN compared to a benchmark population in Germany., Methods: This retrospective study was based on an excerpt of German Statutory Health Insurance data of patients with an initial PN diagnosis between 2012 and 2016. PN cohort contained no record of PN in eight quarters before the index quarter and was followed up for eight quarters (unless deceased). Benchmark cohort without PN was calculated using direct standardization and 1:1 matching to PN cohort., Results: Out of 4,536,002 insured patients, 2309 incident patients with PN were identified and matched to the benchmark cohort out of 3,018,382 patients without PN. Patients were mostly between 45 and 80 years when diagnosed with PN. Higher comorbidity rates were reported for PN than benchmark, with a rising disease burden at follow-up. Most patients with PN (91.3%) were diagnosed outpatient and had >50% more outpatient visits than the benchmark cohort. Hospitalization rates were higher in PN (53.9%) versus benchmark (35.1%), yielding twice longer mean hospital stays for PN (12 days) compared to benchmark (6 days) (p < 0.001). The most common initial therapy for patients with PN was topical corticosteroids (47.6%); ≥10% of patients were treated with antidepressants, antihistamines or systemic corticosteroids. Therapy rates were higher for PN compared to benchmark (p < 0.001). Mean initial costs were twofold higher in PN versus benchmark for outpatient, inpatient and drugs. During follow-up, an increase of >70% in mean PN costs compared to benchmark was identified for outpatient, inpatient and concomitant treatments (p < 0.001)., Conclusion: This study highlights the significantly higher clinical and economic burden incurred by PN compared to benchmark patients in Germany, reflecting the unmet medical need for PN., (© 2023 European Academy of Dermatology and Venereology.)

Rosacea is a common, chronic inflammatory disease characterized by both fluctuating and fixed heterogeneous signs such as facial erythema, papules/pustules, telangiectasia, acute vasodilation (flushing), and phymatous changes, and symptoms such as cutaneous stinging and burning. The shift to a phenotype-based approach to rosacea management has improved the consistency of recommendations across recent published guidelines. Consistent and thorough guidance for the classification, diagnosis, and management of the disease is difficult, as the mechanisms underlying the development of rosacea are still not completely understood nor universally accepted. Here, we provide a critical review of current published guidance, and gaps in the knowledge and management of rosacea. We present the recently approved microencapsulated benzoyl peroxide as an effective topical treatment option for papulopustular rosacea. Benzoyl peroxide (BPO) has been used in acne management for many years; however, many clinicians perceive treatment of rosacea with any BPO formulation to be counterintuitive because of concerns of potential skin irritation, while the lack of an accepted mechanism of action on rosacea pathophysiology means that others may be hesitant to use BPO as a treatment. Minocycline foam 1.5% is also an option for the treatment of inflammatory lesions in rosacea, with a decreased risk of systemic adverse events compared with oral minocycline., (© 2024. The Author(s).)

Background: Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited., Methods: In this randomized, split-face, double-blind study, subjects (age: 17-34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 μg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts., Results: At week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (- 5.9 vs - 2.7; p < 0.0001) with differences between sides noted as early as week 2 (- 1.5 vs - 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity., Conclusions: Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2., Trial Registration: Clinicaltrials.gov NCT04856904., (© 2023. The Author(s).)

Background: Individualization of treatment based on acne type and severity, location, disease burden, and patient preference is required to maximize efficacy, safety, and adherence to therapy. Latin American populations have unique attributes that must be considered as part of this process to improve clinical success and achieve patient goals. Acne is more common among patients with darker skin phototypes, in whom it is often associated with postinflammatory hyperpigmentation and scarring-the most important acne sequelae-potentially due to more frequent and more severe underlying inflammatory processes in this population., Discussion: These data argue for an early and proactive approach to managing acne in these patients with agents that target the inflammatory processes that underlie acne and its sequelae. As a class, retinoids offer a spectrum of activity that may be useful in addressing the unique needs of Latin American populations., Conclusion: Trifarotene, a novel, selective retinoid, has been evaluated in relevant patient populations., (© 2023 The Authors. International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.)

Topical retinoids have an essential role in treatment of acne. Trifarotene, a topical retinoid selective for retinoic acid receptor (RAR) γ, is the most recent retinoid approved for treatment of acne. RAR-γ is the most common isoform of RARs in skin, and the strong selectivity of trifarotene for RAR-γ translates to efficacy in low concentration. Trifarotene, like other topical retinoids, acts by increasing keratinocyte differentiation and decreasing proliferation, which reduces hyperkeratinization. Retinoids have also been shown to inhibit inflammatory pathways via effects on leukocyte migration, toll-like receptors, and Activator Protein (AP)-1. Large-scale randomized, controlled clinical trials have demonstrated trifarotene to be safe, well tolerated, and efficacious in reducing both comedones and papules/pustules of acne. However, unlike all other retinoids, trifarotene is the first topical retinoid with rigorous clinical data on safety and efficacy in truncal acne. Data supporting use of trifarotene to manage acne are reviewed in this publication.

Methyl aminolevulinate (MAL) is a topical compound approved for use with photodynamic therapy (PDT) for the treatment of actinic keratosis (AK) and field cancerization in certain countries. There exists a high burden of disease for patients with AK: repeated treatments are required, there is a known risk of progression to keratinocyte carcinoma, and cosmetic appearance is affected. Delivery of PDT using MAL is a flexible treatment strategy available in many forms; red light, daylight, or artificial daylight can be used for illumination, all of which result in high AK clearance rates and low recurrence. MAL-PDT protocols continue to evolve to further improve adherence and treatment outcomes. Here, we used PubMed to search MEDLINE to identify guidelines, consensus recommendations, and studies describing the use of MAL for the treatment of AK. The aim of this targeted review is to consider various MAL-PDT treatment strategies on the basis of published literature, with a focus on personalizing treatment for the heterogeneous AK population., (© 2023. The Author(s).)

Background: Atopic dermatitis (AD) is associated with chronic pruritus, skin pain, sleep deprivation, depression, and anxiety, which may lead to decreased physical activity (PA). Objective: The aim of the study is to elucidate the impact of disease and itch severity on PA in adult AD. Methods: This is a prospective dermatology practice-based study of 955 AD patients (ages 18-97 years). Results: In multivariable logistic regression models controlling for age, sex, race/ethnicity, and asthma history, patient-reported global AD severity (PtGA), Patient-Oriented Eczema Measure, Eczema Area and Severity Index (EASI), and Investigator's Global Assessment (IGA) were associated with itch impairing light PA, moderate PA, and vigorous PA, as well as higher Patient-Reported Outcomes Measurement Information System Itch Questionnaire PA T -scores. Higher objective Scoring AD (O-SCORAD) was associated with itch impairing moderate PA. In bivariable analyses, performing greater than or equal to 30 minutes of light PA greater than or equal to 1 day a week was decreased with higher PtGA, Patient-Oriented Eczema Measure, and EASI; greater than or equal to 30 minutes of moderate PA greater than or equal to 1 day a week was decreased with PtGA, EASI, O-SCORAD, and IGA; and greater than equal to 30 minutes of vigorous PA was decreased with patient-reported AD severity, EASI, O-SCORAD, and IGA. In multivariable logistic regression models, the impact of itch on PA was inversely associated with light PA, moderate PA, and vigorous PA. Conclusion: Adult AD patients with more severe disease have decreased levels of PA secondary to itch.

Purpose: Establishing a meaningful within-individual change (MWIC) threshold is a key aspect for interpreting scores used as endpoints for evaluating treatment benefit. A new patient-reported outcome (PRO), a sleep disturbance numerical rating scale (SD NRS), was developed in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This research aims to establish a MWIC threshold of the SD NRS score in the context of a drug development program., Methods: An explanatory sequential mixed-methods design was used to address the research objective. This mixed-methods design used phase IIb data and a stand-alone qualitative study. Quantitative anchor-based and distribution-based approaches supported by qualitative-based approaches were conducted, and results were triangulated to determine preliminary MWIC thresholds of the SD NRS score., Results: Triangulation of results from both quantitative and qualitative approaches suggested that a 2- to 6-point decrease in the SD NRS score change constitutes a preliminary range of MWIC threshold estimates., Conclusion: This research determined MWIC threshold estimates for the SD NRS score in both adolescents and adults with moderate-to-severe AD using an explanatory sequential mixed-methods design. This mixed-methods design provides interesting insights for establishing MWIC thresholds of a PRO score in the context of a drug development program., (© 2022. The Author(s).)

Background: Sleep disturbance (SD) is common in atopic dermatitis (AD). We examined the longitudinal course of SD and relationship with itch in AD patients. Methods: A prospective, dermatology practice-based study was performed (N = 1295) where patients were assessed at baseline and follow-up visits. Results: At baseline, 16.9% of the patients had severe SD based on Patient-Reported Outcomes Information System (PROMIS) SD T scores, 19.1% had difficulty falling asleep, 22.9% had difficulty staying asleep, and 34.2% had SD from AD. A total of 31.4% of the patients with difficulty staying asleep at baseline experienced persistent difficulties (for 3 follow-ups or more). Only 17.7% with baseline difficulty falling asleep had persistent disturbance. Despite significant fluctuation in sleep scores, SD generally improved over time. Of the patients facing baseline SD from AD, 31.5% experienced SD at the first visit, and only 12.3% experienced persistent SD at the second follow-up visit. Predictors of increased PROMIS sleep-related impairment T scores over time included baseline PROMIS sleep-related impairment T scores (0.74 [0.68-0.80]), having 3 to 6 nights of itch (2.22 [0.85-3.59]), and severe/very severe AD (4.40 [2.60-6.20]). Conclusions: A significant proportion of adult AD patients, particularly those with moderate-severe AD and frequent itch, had baseline SD. Although sleep scores generally improved over time, many patients experienced a fluctuating or persistent course.

Topical tretinoin has historically been limited by poor tolerability and molecular instability. Research advances have enhanced its efficacy and tolerability, along with reducing oxidation and photodegradation. By overcoming historical limitations, tretinoin use can be extended to patient populations and clinical situations previously not suitable. This review discusses historical limitations of tretinoin, methods employed to overcome those limitations, use within clinical practice, and new formulations of tretinoin for the treatment of acne. J Drugs Dermatol. 2023;22(1):35-40. doi:10.36849/JDD.7146.

Background: Atopic dermatitis (AD) is associated with eczematous lesions, pruritus, pain, and sleep disturbance, which may negatively impact mental health over time., Objective: To determine the predictors and longitudinal course of depressive symptoms in adults with AD., Methods: A prospective, dermatology practice-based study was performed (N = 695). AD signs, symptoms, and severity and patient health questionnaire-9 (PHQ-9) were assessed., Results: At baseline, of the 695 participants, 454 (65.32%) had minimal, 139 (20.00%) had mild, 57 (8.20%) had moderate, 27 (3.88%) had moderately severe, and 8 (2.59%) had severe depression. Most had fluctuating levels of depressive symptoms. Feeling bad, thoughts of self-harm, difficulty concentrating, and slow movement were most persistent. Predictors of persistent depression included older age, non-White race, male sex, public or no insurance, more severe itch, skin pain, facial erythema, nipple eczema, sleep disturbance, and presence of pityriasis alba., Limitations: Single center study., Conclusion: Depressive symptoms are closely related to and fluctuate with AD severity over time. Improved control of AD signs and symptoms, particularly itch, may secondarily improve mental health., Competing Interests: Conflicts of interest Drs Chavda and Gabriel are employees of Galderma. Dr Silverberg has been a consultant for Galderma. Authors Chatrath, Lei, and Yousaf have no conflicts of interest to declare., (Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Importance: The association of acne with emotional and social well-being is not limited to active acne because acne scarring can extend long after cessation of active lesions., Objective: To explore the psychosocial burden of facial and truncal acne (FTA) and acne scars (AS) in a spontaneous manner using qualitative research., Design, Setting, and Participants: This qualitative study recruited participants via local panels. A personification exercise, "Letter to my Disease," was developed for participants of 2 independent arms, FTA and AS, of an international qualitative study in the form of letter completion., Main Outcomes and Measures: Study outcomes comprised perceptions, psychosocial effects of FTA and AS, and coping behaviors., Results: A total of 60 participants were recruited for the FTA and AS study. Among participants with FTA, 17 were women (57%), 21 (70%) were aged 13 to 25 years, and 9 (30%) were aged 26 to 40 years. Twenty-six (87%) participants had severe active acne and 4 (13%) had moderate active acne. Among participants with AS, 18 were women (60%), 9 (30%) were aged 18 to 24 years, and 21 (70%) were aged between 25 and 45 years. Of these 60 participants, 56 (FTA, 28 and AS, 28) completed the projective exercise, "Letter to my Disease," the analysis of which is presented in the current study. During completion of the letter exercise, participants spontaneously expressed emotional and physical burden as well as the social stigma associated with their skin condition. Three major themes emerged, namely, (1) burden of the condition, (2) attitudes and beliefs, and (3) relationship to the personified condition., Conclusions and Relevance: Consistent with their skin condition, participants associated acne, through personification, with the character of an intruder and unwanted companion responsible for their poor self-esteem and emotional impairment. The findings of the joint analyses of letters (FTA and AS), as a catalytic process and free-expression space, outline the continuous burden of active acne starting from adolescence and then continuing into adulthood and beyond active lesions with AS, and highlight the struggle for self-acceptance.

Introduction: Half of the individuals with facial acne develop truncal acne, but the impact of combined facial and truncal acne (CA) on patients' quality of life is poorly researched., Methods: A 60-min interview of 30 participants with CA was conducted that formed the basis for a cross-sectional survey of 694 adolescents and adults with CA., Results: The main themes identified from the qualitative interviews among CA subjects included acceptability to self and others, social functioning and emotional wellbeing. Feelings of embarrassment, self-consciousness and low confidence were experienced often or all the time by over 50% of participants, and were more frequent in those who perceived their acne to be out of control (P = 0.003). Half of patients reported feeling stigmatised because of their CA, and 65.4% believed that others associated their truncal acne with unhealthy or unhygienic habits. Perceived stigma was associated with more feelings of embarrassment (P = 0.005), self-consciousness (P = 0.034) and low self-confidence (P = 0.017). Overall, 64% participants reported that CA interfered with daily life, 46.4% often or always avoided social interaction, 48.6% were often concerned about talking to unfamiliar people and 47.4% were uncomfortable showing affection. Further, 32% and 24.4% participants ≥ 16 years old avoided dating or having romantic/intimate relationships because of their facial and truncal acne, respectively. Social and leisure activities were more frequently negatively impacted among those with perceived uncontrolled CA than among those with controlled CA. Avoiding undressing in front of spouse/partner/friends/relatives was more commonly reported by participants with perceived uncontrolled truncal acne than by those with controlled truncal acne (90.5% versus 80.6%, P = 0.031)., Conclusion: CA is associated with considerable psychological morbidity, with several exacerbating (e.g. perceived stigma) and attenuating factors (e.g. acne being perceived as being under control) that should be accounted for in CA management., (© 2022. The Author(s).)

Objective: We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne., Methods: This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12 years or older with severe facial acne (≥20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and ≤4 nodules). Efficacy outcomes included change from baseline in lesion counts and success (score of 0/1 with ≥2 grade improvement) on investigator global assessment (IGA). Safety was assessed by adverse events and local tolerability., Results: The study enrolled 133 subjects in the T+D group and 69 subjects in the V+P group. The population was balanced, with an approximately even ratio of adolescent (12-17 years) and adult (≥18 years) subjects. The absolute change in lesion counts from baseline were: -69.1 T+D versus -48.1 V+P for total lesions, -29.4 T+D versus -19.5 V+P for inflammatory lesions, and -39.5 T+D versus -28.2 for non-inflammatory lesions ( P <0.0001 for all). Success was achieved by 31.7 percent of subjects in the T+D group versus 15.8 percent in the V+P group ( P =0.0107). The safety and tolerability profiles were comparable between the T+D and V+P arms., Conclusion: T+D was demonstrated to be safe and efficacious as a treatment option for patients with severe acne., Competing Interests: DISCLOSURES: James Del Rosso has acted as a research investigator, consultant and/or speaker for Almirall, Bausch Health (Ortho Dermatology), BiopharmX, Cassiopea, EPI Health, Galderma, JEM Health, La Roche Posay, LEO Pharma, Mayne Pharma, Sol-Gel, Sonoma, Sun Pharma, and Vyne Therapeutics (Foamix); Sandra Marchese Johnson has been advisor or speaker for Nielsen, Amgen, Allergan, Regeneron, Sanofi Genzyme, and Candela, and an investigator for Arcutis, Aurigene, Amgen, Regeneron, Galderma, Nielsen, Dermavant, Lilly, Therapeutics, GSK, Aclaris, Foamix, Novartis, Abbvie, Gage, Cassiopea, National Psoriasis Foundation, University of Pennsylvania; Todd Schlesinger has received equipment/research funding from AbbVie/Allergan, Acrutis, Almirall, Anterios, AOBiome, Astellas Pharma US, Athenex, Biofrontera, Biorasi, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Celgene, Centocor Ortho Biotech (Now Janssen Biotech), ChemoCentryx, Coherus Biosciences, Concert Pharmaceuticals, Corrona, Cutanea Life Sciences, Dermavant, Dermira, DT Pharmacy & DT Collagen, Lilly, EPI Health, Galderma, Janssen Pharmaceuticals, Kiniksa, Leo, Merz, Nestle Skin Health, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sisaf and Trevi, and has acted as in consulting, speaking or advisory capacity for AbbVie, Allergan, Almirall, Amgen, Bioderma, Biofrontera AG, BioPharmx, Bristol Myers Squibb, Castle Biosciences, Celgene, CMS Aesthetics DCME, DUSA/Sun Pharma, Lilly, EPI Health, Foundation for Research and Education in Dermatology (FRED), Galderma, Greenway Therapeutix, Kintor, MED Learning Group, Merz, MJH Associates, Nextphase Therapeutics, Novartis, Ortho Dermatologics, Pharmatecture, Pierre Fabre, Plasmed, Prolacta Bioscience, Regeneron, Remedly, Inc, Sanofi Genzyme, SkinCeuticals/L’Oreal, SUN Pharma, UCB and Verrica; Lawrence Green has served as consultant, investigator or speaker for Almirall, Cassiopea, Galderma, Ortho-Derm, Sol-Gel, SunPharma, and Vyne; Nestor Sanchez has acted as consultant for Galderma; Edward Lain has performed research, consulted, and/or was a member of a speaker bureau for Galderma, Bausch Health, Valeant, Ortho Dermatologics, Novartis, Dr Reddy's, Sol Gel, Vyne, Almirall, Actavis, Cassiopea, and Dermira; Zoe Draelos received a grant from Galderma to function as a research site for the acne project; Jean Phillipe York and Rajeev Chavda are employees of Galderma., (Copyright © 2022. Matrix Medical Communications. All rights reserved.)

Acne vulgaris is typically treated with a combination of a topical retinoid plus an antimicrobial agent, as recommended by national and international evidence-based guidelines around the globe. Adapalene, a synthetic topical retinoid, is available in two concentrations (0.1% and 0.3%) and in once-daily fixed-dose combinations with benzoyl peroxide (BPO) 2.5%. Adapalene 0.3%/BPO 2.5% is approved for use for moderate-to-severe acne with proven efficacy, good safety and tolerability across a spectrum of patient variables (different ages, genders, and skin types) and disease severity. While some patients experience issues with transient tolerability during retinoid and BPO therapy, it is our clinical experience that good patient education to set expectations and provide strategies to minimize irritation can overcome the majority of issues. This article reviews the data supporting the use of adapalene 0.3%/2.5% in practice, including the complementary mechanism of action of adapalene and BPO, clinical data from a range of settings, and key aspects of patient education.

Competing Interests: Conflicts of interest Drs Chavda and Gabriel are employees of Galderma. Dr Silverberg has been a consultant for Galderma. Dr Hong and Authors Lei and Yousaf have no conflicts of interest to declare.

Background: Sleep disturbance (SD) is common in atopic dermatitis (AD). We examined the longitudinal course of SD and relationship with itch in AD patients., Methods: A prospective, dermatology practice-based study was performed (N = 1295) where patients were assessed at baseline and follow-up visits., Results: At baseline, 16.9% of the patients had severe SD based on Patient-Reported Outcomes Information System (PROMIS) SD T scores, 19.1% had difficulty falling asleep, 22.9% had difficulty staying asleep, and 34.2% had SD from AD. A total of 31.4% of the patients with difficulty staying asleep at baseline experienced persistent difficulties (for 3 follow-ups or more). Only 17.7% with baseline difficulty falling asleep had persistent disturbance. Despite significant fluctuation in sleep scores, SD generally improved over time. Of the patients facing baseline SD from AD, 31.5% experienced SD at the first visit, and only 12.3% experienced persistent SD at the second follow-up visit. Predictors of increased PROMIS sleep-related impairment T scores over time included baseline PROMIS sleep-related impairment T scores (0.74 [0.68-0.80]), having 3 to 6 nights of itch (2.22 [0.85-3.59]), and severe/very severe AD (4.40 [2.60-6.20])., Conclusions: A significant proportion of adult AD patients, particularly those with moderate-severe AD and frequent itch, had baseline SD. Although sleep scores generally improved over time, many patients experienced a fluctuating or persistent course., Competing Interests: R.C. and S.G. are employees of Galderma. J.I.S. has been a consultant for Galderma. No other authors have any conflicts of interest to declare., (Copyright © 2022 American Contact Dermatitis Society.)

Itch is a complex symptom that is both common and burdensome in atopic dermatitis (AD). Yet, little is known about the longitudinal course of itch in AD. A prospective, dermatology practice-based study was performed of adults with AD (n = 463). Patients were assessed at baseline and approximately 6, 12, 18 and 24 months. Itch was assessed using Numeric Rating Scale (NRS) average and worst-itch scores, and frequency of itch in the past week. Repeated-measures regression models were constructed to examine itch over time. Overall, 31.5% and 22.5% had moderate (4-6) or severe (7-10) NRS average-itch scores; 27.4% and 36.4% had moderate (4-6) or severe (7-10) NRS worst-itch scores; 12.7% and 62.0% had itch from eczema 3-4 and ≥ 5 days in the past week; 27.4% and 45.1% reported sometimes and often/almost always having itch, respectively. Among patients with baseline moderate (4-6) or severe (7-10) NRS average-itch scores, 21.2% and 16.3% continued to have moderate or severe scores at ≥ 1 follow-up visits. In repeated-measures regression models, persistent NRS average-itch scores were associated with baseline NRS average-itch [adjusted β (95% CI): 0.75 (0.68, 0.82)] and food allergy [- 0.45 (- 0.84, - 0.07)]. Persistent NRS worst-itch was associated with baseline worst-itch NRS [0.73 (0.66, 0.80)] and Medicaid insurance [1.06 (0.17, 1.94)]. AD patients had a heterogeneous longitudinal course with fluctuating and complex overlapping patterns of average- and worst-itch intensity, and frequency., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Prurigo nodularis (PN) is an understudied, pruritic inflammatory skin disease. Little is known about the effect of PN on quality of life and its associated economic burden., Objective: To quantify the impact of PN on quality of life and its economic implications., Methods: A cohort study of PN patients (n = 36) was conducted using the Health Utilities Index Mark 3 questionnaire. Control data from US adults (n = 4187) were obtained from the 2002-2003 Joint Canada/United States Survey of Health. Quality-adjusted life year loss and economic costs were estimated by comparing the Health Utilities Index Mark 3 scores of the PN patients with those of the controls., Results: The PN patients had lower overall health performance compared to the controls, (mean ± SE, 0.52 ± 0.06 vs 0.86 ± 0.003, respectively, P < .001). In multivariable regression, PN was found to be associated with worse health performance (coefficient -0.34, 95% CI [-0.46 to -0.23]), most prominent in the pain subdomain (coefficient -0.24, 95% CI [-0.35 to -0.13]). This correlated to an average of 6.5 lifetime quality-adjusted life years lost per patient, translating to an individual lifetime economic burden of $323,292 and a societal burden of $38.8 billion., Conclusion: These results demonstrate that PN is associated with significant quality-of-life impairment, similar to the level of other chronic systemic conditions. PN is also associated with a substantial individual economic burden, emphasizing the necessity of research on effective treatment options., Competing Interests: Conflicts of interest Dr Kwatra is an advisory board member/consultant for Abbvie, Celldex Therapeutics, Galderma, Incyte Corporation, Pfizer, Regeneron Pharmaceuticals, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Kiniksa Pharmaceuticals, Pfizer Inc, and Sanofi. Drs Gabriel, Chavda, and Semenov and Authors Whang, Le, Khanna, Williams, Roh, Sutaria, and Choi have no conflicts of interest to declare., (Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Acne affects more than 80% of adolescents and young adults, who most often develop acne scars. Supporting data on the effect of acne scars on patient's health-related quality of life (HRQOL) are limited., Objective: The aim was to determine how the severity of acne scars impacts the HRQOL of afflicted individuals., Methods: In this population-based cross-sectional study, 723 adults with facial acne scars but without active acne lesions self-completed the Self-assessment of Clinical Acne-Related Scars (SCARS) questionnaire formulated to investigate degree of acne scarring. The Facial Acne Scar Quality of Life (FASQoL), Dermatology Life Quality Index (DLQI), and Dysmorphic Concern Questionnaire (DCQ) were completed to assess the attitude of these patients toward their scars and the impact of scarring on their HRQOL., Results: The mean (standard error) DLQI score for facial acne scars was 6.26 (0.22). Acne scars were considered a 'very large' or 'extremely large' concern by 19.3% of participants with mild scars as compared to 20.1% and 34.0% of participants with moderate and severe/very severe scars, respectively (P = 0.003). Higher FASQoL scores were associated with increased severity of scarring (P = 0.001). In total, 16.9% of participants had clinical features of dysmorphia (i.e., DCQ > 13). DCQ scores were significantly higher among participants with more severe scarring (mean DCQ score of 8.04 [0.28], 8.40 [0.18], and 10.13 [0.08] among participants with mild, moderate, and severe/very severe acne scars, respectively; P = 0.001). Most commonly reported signs of emotional distress were self-consciousness (68.0%) and worry about scars not going away (74.8%)., Conclusions: This study highlights the significant psychosocial impact of atrophic acne scars in the form of embarrassment and self-consciousness. Individuals with mild scars also expressed significant impact on quality of life that increased with aggravation of scar severity. Patient-reported outcomes provide an insight into the physical, functional, and psychological impact of acne scarring from the patient's perspective., (© 2021. The Author(s).)

Background: Most people with acne are at risk of developing acne scars, but the impact of these scars on patients' quality of life is poorly researched., Objective: To assess the perspective of patients with acne scars and the impact of these scars on their emotional well-being and social functioning., Methods: A 60-minute interview of 30 adults with acne scars informed and contextualized the development of a cross-sectional survey of 723 adults with atrophic acne scars., Results: The main themes identified in the qualitative interviews included acceptability to self and others, social functioning, and emotional well-being. In the cross-sectional survey, 31.6%, 49.6%, and 18.8% of the participants had mild, moderate, and severe/very severe acne scarring. The survey revealed that 25.7% of the participants felt less attractive, 27.5% were embarrassed or self-conscious because of their scars, 8.3% reported being verbally and/or physically abused because of their scars on a regular basis, and 15.9% felt that they were unfairly dismissed from work. In addition, 37.5% of the participants believed that their scars affected people's perceptions about them, and 19.7% of the participants were very bothered about hiding their scars daily. Moreover, 35.5% of the participants avoided public appearances, and 43.2% felt that their scars had negatively impacted their relationships., Limitations: The temporal evaluation of the impact was not estimated., Conclusion: Even mild atrophic acne scarring can evoke substantial emotional, social, and functional concerns., Competing Interests: Dr Tan has acted as a consultant for and/or received grants/honoraria from Bausch, 10.13039/501100009754Galderma, 10.13039/100004319Pfizer, Almirall, Boots/10.13039/100005153Walgreens, Botanix, Cipher, 10.13039/501100009754Galderma, Novan, 10.13039/100004336Novartis, Promius, 10.13039/501100004296SUN, and Vichy. Dr Beissert has acted as an advisor for AbbVie Deutschland GmbH & Co, Actelion Pharmaceuticals GmbH, Allmirall-Hermal GmbH, Amgen GmbH, Celgene GmbH, Galderma Laboratorium GmbH, Janssen-Cilag GmbH, Leo Pharma GmbH, Lilly Deutschland GmbH, Menlo Therapeutics, MSD Sharp & Dohme GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Sanofi-Aventis Deutschland GmbH, and UCB Pharma GmbH and has received speaker honorarium from Novartis Pharma GmbH, AbbVie, MSD, Pfizer, Janssen-Cilag, Roche-Posay, Actelion, GSK, BMS, Celgene, Allmirall, and Hexal-Sandoz. Dr Cook-Bolden has acted as an advisor, consultant, investigator, and/or speaker and has received grants/honoraria from Almirall, Cassiopea, Foamix Pharmaceuticals, 10.13039/501100009754Galderma, and Ortho Dermatologics. Dr Chavda is an employee of Galderma. Dr Harper has acted as an advisor, consultant, and/or speaker and has received honoraria from Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI Health, Galderma, LaRoche-Posay, Ortho Dermatologics, Sol-Gel Technologies, Sun, and Vyne. Dr Hebert has acted as an advisor, consultant, investigator, and/or speaker and has received grants/honoraria from 10.13039/100007819Allergan, Cassiopea, 10.13039/501100009754Galderma, GSK, La Roche-Posay, Novan, Ortho Dermatologics, Ortho Dermatologics, 10.13039/100009857Regeneron 10.13039/100004339Sanofi, and Vyne. Dr Lain has acted as an advisor, consultant, investigator, and/or speaker and has received grants/honoraria from 10.13039/100006483AbbVie, Aclaris Therapeutics Inc, 10.13039/100007819Allergan Inc, Almirall, 10.13039/100004325AstraZeneca, Athenix, Biopelle Inc, BioPharmX, Biorasi LLC, BMS, Brickell Biotech Inc, Cassiopea SpA, 10.13039/100006436Celgene, Cellceutix, ChemoCentryx, Cutanea Life Sciences, Demira, Dow Pharmaceutical Sciences Inc, Dr Reddy's Laboratory, 10.13039/100004312Eli Lilly and Company, Gage Development Company LLC, Galderma Laboratories L.P., 10.13039/501100009754Galderma, Hovione, Kadmon Corporation LLC, La Roche-Posay, Leo Pharma, 10.13039/501100004628MedImmune, Menlo Therapeutics, Moleculin LLC, Neothetics, Nielsen Holdings N.V, 10.13039/100004336Novartis, Othro Dermatologics, 10.13039/100004319Pfizer Inc, Promius Pharma LLC, Sebacia Inc, Sienna Labs Inc, SkinCeuticals LLC, Sol-Gel Technologies, 10.13039/100011110UCB, and Valeant Pharmaceuticals North America LLC. Dr Layton has acted as an advisor, consultant, investigator, and/or speaker and has received grants/honoraria from 10.13039/501100009754Galderma, GSK, L'Oreal, La Roche-Posay, Origimm, Leo Pharma, and Proctor & Gamble. Dr Rocha has acted as an advisor and/or speaker and has received honoraria from Eucerin, Galderma, Johnson & Johnson, and Leo Pharma. Dr Weiss has acted as an advisor, consultant, investigator, and/or speaker and has received grants/honoraria from Almirall, Bausch, Cassiopea, Cutera, EPI Health, Foamix, 10.13039/501100009754Galderma, and Ortho Dermatologics. Dr Dréno has acted as an advisor, consultant, and/or speaker and has received honoraria from BMS, Galderma, La Roche-Posay, Merck Serono, Pierre Fabre, and Sanofi., (© 2021 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.)

Background and Objectives: Trifarotene is a topical retinoid selective for retinoic acid receptor gamma that was recently approved for treatment of acne vulgaris. We performed a gene expression analysis to identify the molecular and cellular impact of trifarotene treatment on acne papules. Methods: In this open-label prospective study, subjects with moderate inflammatory acne of the back were treated with trifarotene 0.005% or vehicle cream on dedicated areas for 27 days, and 4 biopsies were collected from each subject (1 from skin without a visible acne lesion and three at the site of an acne papule: one baseline, one after vehicle treatment, and one after trifarotene treatment). Large scale gene expression profiling of the biopsies was performed using Affymetrix technology, treatment-specific gene expression profiles were generated using statistical modeling, and pathway analysis was performed. Using single-cell RNAseq data, in silico deconvolution of transcriptomics data was performed to identify cellular signatures. Results: We discovered a unique set of 67 genes modulated by trifarotene that are primarily involved in cellular migration, inflammation, and extracellular matrix reorganization. Changes in cellular expression were similar in both trifarotene-treated and spontaneously-resolving lesions. However, only trifarotene treatment impacted SPP1 + macrophages, a subset of highly proliferative macrophages recently identified in fibrotic tissue. Conclusions: These results show that trifarotene has a novel action in acne treatment by affecting epidermal and immune components of acne pathogenesis., Competing Interests: RC, VJ, and JKK are employees of Galderma; SB-R is an employee of Syneos Health and consultant for Galderma; BD and AK are investigators and consultants for Galderma., (Copyright © 2021 Dreno, Chavda, Julia, Khammari, Blanchet-Réthoré and Krishnaswamy.)

Background: Itch is a complex and burdensome symptom in atopic dermatitis (AD). Severity of scratching/excoriation (SCORAD-scratch) has been found to be a valid measure of itch in AD. However, little is known about the longitudinal course of scratching/excoriations in AD., Methods: A prospective, dermatology practice-based study was performed of adults with AD (N = 399). The patients were assessed at baseline and approximately 6, 12, 18, and 24 months., Results: Severity of excoriations correlated best with the Numerical Rating Scale-worst itch (Spearman correlation, ρ = 0.50), followed by a Patient-Reported Outcome Measurement Information System Itch Questionnaire-scratching behavior T score (ρ = 0.48), Numerical Rating Scale-average itch (ρ = 0.41), relative frequency of itch (ρ = 0.36), and frequency of itch from eczema (ρ = 0.29, all P < 0.0001). Scratching severity showed good reliability (intraclass correlation coefficient range = 0.62-0.69). Overall, 30.6% and 5.5% had moderate (2) or severe (3) SCORAD-scratch scores. Among patients with baseline moderate (2) or severe (3) SCORAD-scratch scores, 18.9% and 13.6% continued to have moderate or severe scores at 1 or more follow-up visits. In repeated-measures regression models, persistent SCORAD-scratch scores were associated with baseline severity of excoriations (adjusted β [95% confidence interval] = 0.51 [0.37 to 0.65]), Medicaid insurance (-0.35 [-0.65 to -0.04]), and Eczema Area and Severity Index scores (0.03 [0.02 to 0.04])., Conclusions: Adult AD patients had a heterogeneous longitudinal course with fluctuating severity of excoriations., Competing Interests: The authors have no relevant conflicts of interest to declare., (Copyright © 2021 American Contact Dermatitis Society. All Rights Reserved.)

Background: Patient-Reported Outcomes Measurement Information System Global Health (PGH) was validated to assess health-related quality of life in several diseases. Little is known about its measurement properties in adult atopic dermatitis., Objective: Examine the measurement properties of PGH in adult atopic dermatitis., Methods: A prospective dermatology practice-based study of 994 atopic dermatitis patients (18-97 years)., Results: PGH physical and mental health 4-item and abridged 2-item T scores, as well as mapped EuroQol-5D score, showed strong to very strong correlation with one another and moderate to strong Spearman correlations with Patient-Oriented Scoring Atopic Dermatitis, Patient-Health Questionnaire-9, Patient-Reported Outcomes Measurement Information System sleep disturbance and related impairment, Eczema Area and Severity Index, objective Scoring Atopic Dermatitis; and weak to moderate correlations with Patient Oriented Eczema Measure, numeric rating scale worst itch and average itch, and Scoring Atopic Dermatitis. The Dermatology Life Quality Index (DLQI) had stronger correlations with Patient Oriented Eczema Measure, Patient-Oriented Scoring Atopic Dermatitis, numeric rating scale worst itch and average itch, Eczema Area and Severity Index, and Scoring Atopic Dermatitis, but weaker correlations with Patient-Health Questionnaire-9 and Patient-Reported Outcomes Measurement Information System sleep disturbance and related impairment (convergent/divergent validity). PGH and DLQI scores had similarly poor ability to differentiate between levels of self-reported global atopic dermatitis severity (known-groups validity). No floor or ceiling effects were observed. No PGH or DLQI items had differential item functioning by demographics. PGH and DLQI scores showed fair to good responsiveness. Finally, PGH and DLQI showed similarly good test-retest reliability., Limitations: Single-center study., Conclusion: PGH scores had sufficient validity and reliability to assess health-related quality of life in atopic dermatitis., Competing Interests: Conflicts of interest Drs Chavda and Gabriel are employees of Galderma. Dr Silverberg has been a consultant and advisory board member for Galderma. Dr Janmohamed, Vakharia, Chopra, Patel, Singam, Kantor, and Hsu and Authors Schwartzman, Lei, and Yousaf have no conflicts of interest to declare., (Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Patients with atopic dermatitis (AD) have heterogeneous clinical phenotypes, including different combinations of itch and lesional severity. Little is known about the characteristics and course of these subtypes., Objective: To determine the characteristics, associations, burden, and course of patients with AD using combined itch and lesional severity., Methods: A prospective practice-based study was performed using questionnaires and physical examination (n=592). AD subsets were defined using verbal rating scale for average itch combined with either eczema area and severity index, objective-scoring atopic dermatitis (SCORAD), or validated investigator's global assessment as follows: mild-moderate itch and lesions (MI-ML), mild-moderate itch and severe lesions (MI-SL), severe itch and mild-moderate lesions (SI-ML), and severe itch and lesions (SI-SL)., Results: At baseline, there were only weak-moderate correlations of numerical rating scales for worst itch or average itch or SCORAD itch with eczema area and severity index, objective-SCORAD, body surface area, and validated investigator's global assessment (Spearman's rho = 0.32-0.62). Most patients had MI-ML (59.4%-62.3%), followed by SI-ML (21.3%-29.1%), SI-SL (6.0%-12.9%), and MI-SL (3.8%-6.4%). Patients with SI-SL, followed by SI-ML and MI-SL, described their AD as being more severe overall and had worse impairment in sleep, mental health, and quality of life. However, those with MI-SL or SI-SL were far more likely to be classified as severe by a physician (multivariable logistic and linear regression, P < .005 for all). Baseline MI-SL, SI-ML, and SI-SL were associated with similar longitudinal courses over time and more AD flares and itch triggers than MI-ML., Conclusion: Combined itch and lesional severity seem to describe unique AD phenotypes. Further studies are needed to confirm these findings and understand the optimal treatments for these groups., (Copyright © 2021 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Few outcome measures were validated for assessing depressive symptoms in AD. Patient Health Questionnaire-9 (PHQ9) and the abridged PHQ2 are established patient-reported outcome measures of depressive symptoms., Objective: We sought to examine the measurement properties of PHQ9 and PHQ2 in adult AD. A prospective dermatology-practice based study of 458 AD patients (age 18-97 years) was conducted., Results: PHQ9 strongly correlated with Dermatology Life Quality Index, Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Disturbance and Sleep-Related Impairment, and PROMIS Itch Questionnaire Mood and Sleep (PIQ-MS), and moderately correlated with Patient-Oriented Eczema Measure, Numeric Rating Scale (NRS) average-itch, NRS-sleep, Eczema Area and Severity Index, Scoring AD and Rajka-Langeland scores. PHQ2 had significantly weaker correlations than PHQ9 with PROMIS SD, SRI and PIQ-MS, but similar correlations with other outcomes. PHQ9 and PHQ2 had good discriminant validity. Changes from baseline in PHQ9 and PHQ2 were poorly or weakly correlated with changes of the other outcome measures. There was no differential item functioning of PHQ items. PHQ9 showed good reliability (intraclass correlation coefficient range: 0.80-0.87). PHQ2 had slightly lower reliability (0.76-0.82)., Conclusions: PHQ9 and PHQ2 had similar measurement properties, but PHQ2 was more feasible to assess depressive symptoms in AD., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2020 American Contact Dermatitis Society. All Rights Reserved.)

Background: Acne confers an increased risk of physical, psychiatric, and psychosocial sequelae, potentially affecting multiple dimensions of health-related quality of life (HRQoL). Morbidity associated with truncal acne is poorly understood., Objective: To determine how severity and location of acne lesions impact the HRQoL of those who suffer from it., Methods: A total of 694 subjects with combined facial and truncal acne (F+T) and 615 with facial acne only (F) participated in an online, international survey. Participants self-graded the severity of their acne at different anatomical locations and completed the dermatology life quality index (DLQI)., Results: The F+T participants were twice as likely to report "very large" to "extremely large" impact on HRQoL (ie, DLQI > 10 and children's DLQI [CDLQI] > 12) as compared with the F participants (DLQI: odds ratio [OR] 1.61 [95% confidence interval {CI} 1.02-2.54]; CDLQI: OR 1.86 [95% CI 1.10-3.14]). The impact of acne on HRQoL increased with increasing acne severity on the face (DLQI and CDLQI P values = .001 and .017, respectively), chest ( P  = .003; P  = .008), and back ( P  = .001; P  = .028)., Limitations: Temporal evaluation of acne impact was not estimated., Conclusions: Facial and truncal acne was associated with a greater impact on HRQoL than facial acne alone. Increasing severity of truncal acne increases the adverse impact on HRQoL irrespective of the severity of facial acne., Competing Interests: Dr Tan has acted as a consultant for and/or received grants/honoraria from Bausch, 10.13039/501100009754Galderma, 10.13039/100004319Pfizer, Almirall, Boots/10.13039/100005153Walgreens, Botanix, Cipher, 10.13039/501100009754Galderma, Novan, 10.13039/100004336Novartis, Promius, 10.13039/501100004296Sun, Vichy. Dr Chavda is an employee of Galderma. Dr Beissert, Dr Cook-Bolden, Dr Harper, Dr Hebert, Dr Lain, Dr Layton, Dr Weiss, and Pr Dréno have acted as investigators and consultants for Galderma. Dr Rocha has acted as an advisor and/or speaker and received honoraria from Eucerin, Galderma, Johnson&Johnson and Leo Pharm., (© 2021 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.)

Introduction : Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by intensely pruritic, hyperkeratotic nodules distributed on the trunk and extensor surfaces of the extremities. PN has a profoundly negative impact on sleep and quality of life in patients with PN. There are currently no U.S. Food and Drug Administration-approved agents and patients are often recalcitrant to current therapies, highlighting the importance of further research into this severely debilitating condition. Areas covered : A PubMed search was conducted to find available literature on the pathophysiology and clinical management of PN. In this review article, we discuss the current understanding of the pathophysiology, recommended diagnostic approach, and treatment options available for PN. Expert opinion/commentary : PN is an extremely difficult condition to treat, because there is a lack of effective therapies available due to our limited understanding of its pathophysiology. Currently, available treatment options are often multimodal due to the intersection of neuroimmune etiologic factors in the pathogenesis of PN. Fortunately, as our knowledge of PN expands, novel treatments targeting specific molecular biomarkers of PN are emerging, providing hope to this long-suffering patient population.

Background: Little is known about the longitudinal course of adult atopic dermatitis (AD) lesional severity and extent in clinical practice., Objective: To determine the longitudinal course of AD in clinical practice., Methods: A prospective, dermatology practice-based study was performed (n = 400). Patients were assessed at baseline and approximately 6, 12, 18, and 24 months by eczema area and severity index (EASI) and objective-scoring atopic dermatitis (objective-SCORAD). Multivariable repeated measures linear regression models were constructed to evaluate AD severity over time., Results: Overall, 36.2% and 18.2% of patients had moderate (6.0-22.9) or severe (23.0-72.0) EASI scores at any visit, respectively. Similarly, 29.0% and 26.4% of patients had moderate (24.0-37.9) or severe (38.0-83.0) objective-SCORAD scores at any visit, respectively. Among patients with baseline moderate (6.0-22.9) or severe (23.0-72.0) EASI scores, 25.0% and 18.6% continued to have moderate or severe scores at 1 or more follow-up visits, respectively. Similarly, among patients with baseline moderate (24.0-37.9) or severe (38.0-83.0) objective-SCORAD scores, 22.6% and 24.5% continued to have moderate or severe scores at 1 or more follow-up visits, respectively. In longitudinal regression models, EASI was significantly associated with body surface area (adjusted β [95% confidence interval]: 0.16 [0.09-0.23]) and edema/papulation (2.31 [0.19-4.43]). In addition, objective-SCORAD was significantly associated with body surface area (0.12 [0.04-0.21]), edema/papulation (4.69 [2.05-7.32]), and scratch (3.34 [0.45-6.24]) over time., Conclusion: AD lesional severity has a heterogeneous longitudinal course. Many patients had fluctuating lesional severity scores over time. A minority of patients had persistently moderate or severe lesions over time. Most patients with moderate-severe disease at baseline were unable to achieve persistent lesional clearance., (Copyright © 2020 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Prurigo nodularis is an itchy skin disease with unknown epidemiology. This study aimed to describe the epidemiology of prurigo nodularis compared with that of psoriasis. The German sickness fund claims database, with 2,783,175 continuously insured patients, included 1,720 patients diagnosed with prurigo nodularis and 51,390 with psoriasis. Patients with prurigo nodularis were averagely 8 years older than psoriasis patients and more often were women (p < 0.001). Annual incidence was a constant 0.02% in prurigo nodularis, and decreased steadily from 0.53 to 0.42% in psoriasis; cumulative incidence was 0.1% for prurigo nodularis and 1.9% for psoriasis. Prevalence was 0.1% for prurigo nodularis and 4.7% for psoriasis, with a 1-year mortality of 5.4% for prurigo nodularis and 1.2% for psoriasis (p < 0.001). The most frequent pre-existing comorbidities in patients with prurigo nodularis were inflammatory dermatoses and depression. This epidemiological study found a low prevalence of prurigo nodularis, manifesting different demographics and comorbidities compared with psoriasis.

Background: Atopic dermatitis (AD) is associated with itch, pain, and sleep disturbance, all of which may contribute toward cognitive dysfunction., Objective: To determine the relationship of AD severity and cognitive function in adults., Methods: We performed a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 386). Cognitive function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function 8-item Short-Form., Results: At baseline, 118 patients (58.1%) reported ≥1 symptoms of cognitive dysfunction in the past 4 weeks, with 29 (14.3%) having mild, 11 (5.4%) moderate, and 4 (2.0%) severe PROMIS Cognitive Function T-scores. In propensity score-weighted regression models, PROMIS Cognitive Function T-scores were inversely associated with patient-reported global AD severity, Patient Oriented Eczema Measure (POEM), Numeric Rating Scale worst itch and skin pain, SCORing Atopic Dermatitis (SCORAD)-sleep, POEM-sleep, Eczema Area and Severity Index, and SCORAD, with stepwise decreases of cognitive function with worsening AD severity. At all AD severity levels, cognitive dysfunction was associated with increased Dermatology Life Quality Index and ItchyQoL scores. Changes from baseline in PROMIS Cognitive Function T-scores were weakly to moderately inversely correlated with changes from baseline in multiple AD outcomes., Limitations: Single-center study without non-AD controls., Conclusion: Cognitive dysfunction is associated with AD severity. Cognitive function may be an important end point for monitoring treatment response in AD., (Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Atopic dermatitis (AD) is associated with heterogeneous triggers of itch, which may affect AD course and severity., Objective: To characterize the triggers of itch in adult AD., Methods: This was a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 587). Thirteen itch triggers were assessed using the patient-reported outcomes measurement information system Itch-Triggers., Results: Overall, 381 (64.9%) patients reported greater than or equal to 1 itch trigger in the past week and 212 (36.1%) reported greater than or equal to 3 itch triggers. The most commonly reported triggers were stress (35.4%), sweat (30.5%), weather change (24.7%), dry air (24.4%), and heat (24.0%). In multivariable Poisson regression models, the number of itch triggers was associated with more severe patient-reported global AD severity, Numeric Rating Scale worst itch, Patient-Oriented Eczema Measure, Scoring Atopic Dermatitis sleep, Numeric Rating Scale skin pain, Eczema Area and Severity Index, and objective Scoring Atopic Dermatitis. The seasonality of AD was associated with distinct itch triggers. In multivariable logistic regression models, the number of itch triggers was associated with less than or equal to 3 months of AD remission during the year, greater than or equal to 2 AD flares, and AD being worse during some seasons. Four patterns of itch triggers were identified using latent class analysis, each associated with different clinical characteristics., Conclusion: Itch triggers are common and affect the course of AD. Itch triggers are an important end point to assess in patients with AD., (Copyright © 2020 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

There is a paucity of literature covering patient-reported outcomes of treatments for truncal acne. Trifarotene 50 μg/g cream is a novel retinoid molecule approved for once-daily topical treatment of facial and truncal acne vulgaris. As physicians are starting to gain real-world experience with this retinoid treatment, their access to reporting from the patient's perspective provides a valuable adjunct to the pivotal studies. We report a case series of three subjects with moderate facial and truncal acne treated with trifarotene 50 μg/g cream on the face, shoulders, upper back and upper anterior chest for 12 weeks and evaluated by satisfaction questionnaires. This case series illustrating the treatment of facial and truncal acne with trifarotene 50 μg/g cream, in the form of real-world data, describes high overall satisfaction and excellent tolerability to support the use of this new retinoid molecule in the treatment of acne vulgaris on both the face and trunk.

Background: An Investigator Global Assessment (IGA) is recommended by health agencies for drug registration in atopic dermatitis (AD). Current IGA scales lack standardization., Objectives: To develop an IGA scale, training module, and clinical certification examination for use in AD trials; establish content validity; and assess reliability., Methods: Expert dermatologists participated in the development of the validated IGA for AD (vIGA-AD TM ). Reliability (interrater and intrarater) was assessed by 2 web-based surveys. Clinical certification for investigators consisted of a training module and examination., Results: Expert consensus was achieved around a 5-point IGA scale including morphologic descriptions, and content validity was established. Survey 1 showed strong interrater reliability (Kendall's coefficient of concordance W [Kendall's W], 0.809; intraclass correlation [ICC], 0.817) and excellent agreement (weighted kappa, 0.857). Survey 2, completed 5 months after training of dermatologists, showed improvements in scale reliability (Kendall's W, 0.819; ICC, 0.852; weighted kappa, 0.889). In this study, 627 investigators completed vIGA-AD training and certification., Limitations: Ratings were assessed on photographs., Conclusion: A validated IGA scale and training module were developed with the intent of harmonizing assessment of disease severity in AD trials. Strong reliability and excellent agreement between assessments were observed., (Copyright © 2020. Published by Elsevier Inc.)

Background: The ideal patient-reported outcome measure to assess sleep disturbance in atopic dermatitis (AD) has not been determined., Objective: We sought to determine the measurement properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire Mood and Sleep (PIQ-MS), Sleep Disturbance (SD), Sleep-Related Impairment (SRI), and Epworth Sleepiness Scale (ESS) in adults with AD., Methods: A prospective dermatology practice-based study was performed using questionnaires and evaluation by a dermatologist (n=611)., Results: PIQ-MS, PROMIS SD, SRI, and ESS had good convergent validity with intensity and frequency of sleep disturbance, Patient-Oriented Eczema Measure, Eczema Area and Severity Index, total and objective-Scoring AD, Numerical Rating Scale of worst-itch and average-itch, and Dermatology Life Quality Index. PIQ-MS had significantly better correlations with other severity measures than the other sleep measures (Fisher z-scores, P≤0.007). PIQ-MS, and to lesser extent PROMIS SD, PROMIS SRI and ESS had good discriminant validity. All four sleep assessments showed fair responsiveness to change of severity of sleep-disturbance, AD and itch. PIQ-MS had the best reliability. PIQ-MS, PROMIS SD, SRI and ESS showed good internal consistency and were feasible for use in clinical practice., Conclusions: PIQ-MS, followed by PROMIS SD, had the best construct validity and reliability in adult AD.

Background: Little is known about the measurement properties of Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD) in adults with atopic dermatitis (AD). Even less is known about how PO-SCORAD performs compared with the Patient-Oriented Eczema Measure (POEM)., Objective: To examine the measurement properties of PO-SCORAD and compare them with those of POEM., Methods: A prospective dermatology practice-based study of 291 patients with AD (age range, 18-72 years)., Results: PO-SCORAD and POEM were moderately correlated with each other (Spearman ρ = 0.56) and had weak-moderate correlations with the Numeric Rating Scale (NRS) worst itch and average itch, Dermatology Life Quality Index (DLQI), ItchyQOL, Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI), Patient Health Questionnaire-9 (PHQ-9), and Eczema Area and Severity Index (EASI) (P < .001). POEM had significantly stronger correlations with DLQI, ItchyQOL, and EASI than did PO-SCORAD. PO-SCORAD and POEM had fair discriminant validity. Changes from baseline in PO-SCORAD and POEM were moderately correlated with each other; were weakly to strongly correlated with NRS worst itch and average itch, DLQI, ItchyQOL, PROMIS SD, PROMIS SRI, PHQ-9, and EASI; and had good test-retest reliability. There was no differential item functioning of items or floor or ceiling effects for PO-SCORAD or POEM. The thresholds for meaningful change for PO-SCORAD and POEM were -15.5 and -5.0, respectively. Median completion times for PO-SCORAD and POEM were 3 minutes and 1 minute, respectively., Conclusion: PO-SCORAD and POEM had good construct and cross-cultural validity, reliability, and responsiveness in adults with AD and were feasible for use in clinical trials and practice. However, POEM had better measurement properties than PO-SCORAD., (Copyright © 2020 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: The optimal approaches for monitoring sleep disturbances in adults with atopic dermatitis (AD) is not established. Multiple patient-reported outcome measures for AD and itch have sleep-related items. These items have not been validated previously., Objective: Assess the measurement properties of sleep-related items from the Patient-Oriented Eczema Measure (POEM), SCORing AD (SCORAD), 5-dimensions of itch (5D), and ItchyQOL in adults with AD., Methods: We performed a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 115)., Results: There was modest overlap and weak-moderate concordance of responses to the different assessments. Regarding concurrent validity, POEM-sleep, SCORAD-sleep, 5D-sleep, and ItchyQOL-sleep showed moderate correlations with each other. Regarding convergent validity, all items showed moderate correlation with total POEM, but weak correlations with Eczema Area and Severity Index (EASI), objective and total SCORAD, moderate to strong correlations with mean ItchyQOL and Dermatology Life Quality Index (DLQI), but poor or no significant correlation with Numeric Rating Scale (NRS) for worst or average itch. Regarding discriminant validity, all items showed significant and stepwise increases with increasing self-reported and physician-reported AD severity (Kruskal-Wallis, P < .01 for all). Floor effects were observed for POEM-sleep (n = 53, 46.1%), SCORAD-sleep (n = 28, 24.4%), 5D-sleep (n = 41, 35.7%), and ItchyQOL-sleep (n = 33, 28.7%); no ceiling effects were observed. Change in sleep-related item scores showed moderate strong correlations with change in POEM, 5Ditch, mean ItchyQOL, DLQI, objective and total SCORAD, and EASI, but inconsistent correlations with change of itch severity., Conclusion: Sleep-related items from POEM, SCORAD, 5D and ItchyQOL showed good validity and responsiveness to monitor sleep disturbances in adult AD patients., (Copyright © 2019 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Randomized controlled studies of combination therapies in rosacea are limited., Objective: Evaluate the efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (ie, 30-mg immediate-release and 10-mg delayed-release beads) (DMR) versus IVM and placebo for treatment of severe rosacea., Methods: This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA] score, 4) to receive either IVM and DMR (combination arm) or IVM and placebo (monotherapy)., Results: A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs -73.6% for monotherapy [P = .032]) and IGA score (P = .032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving an IGA score of 0 (11.9% vs 5.1% [P = .043]) and 100% lesion reduction (17.8% vs 7.2% [P = .006]) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index score, and ocular signs/symptoms and were well tolerated., Limitations: The duration of the study prevented evaluation of potential recurrences or further improvements., Conclusion: Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in cases of severe rosacea., (Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Most patients with mycosis fungoides are diagnosed with early-stage disease. However, prevalence of early-stage disease is unknown, and evidence of its burden is scarce. The aim of this study is to estimate the prevalence of early-stage mycosis fungoides, how long patients live with early-stage disease and to characterise these patients. Data were obtained from 4 key publications and from US cancer registries (Surveillance, Epidemiology and End Results Program; SEER). The derived incidence of early-stage mycosis fungoides was 0.26/100,000 (UK), 0.29/100,000 (US) and 0.38/100,000 (US-SEER) and the prevalence was 4.8/100,000 (UK), 5.2/100,000 (US) and 6.6/100,000 (US-SEER). Early-stage disease may last for 18 years. From SEER registries, 3,132 were diagnosed at early stage (mostly stage IA). Median age at diagnosis was 58 years. Compared with stage IA, the relative risk of death was 1.3 for stage IB and 3.5 for stage IIA. We confirm the rarity of early-stage mycosis fungoides, a differential prognosis and the potential for elevated burden of disease.

F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.

Background: Scarring is a frequent consequence of acne., Objectives: Our objective was to evaluate the effect of up to 48 weeks' treatment with adapalene 0.3%/benzoyl peroxide 2.5% (A0.3/BPO2.5) gel on atrophic scars in moderate or severe acne vulgaris., Methods: In Part 1 of this two-part study, A0.3/BPO2.5 gel or vehicle was applied on each half-face for 24 weeks in a randomized, investigator-blinded, split-face design. Part 2 was a 24-week, open-label extension phase during which A0.3/BPO2.5 gel was applied on both sides of the face. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, local tolerability, and safety., Results: Of the 45 subjects entering Part 2, 41 completed the 48-week study. At baseline (Part 1), most subjects had moderate acne (93.3%) with mild scars (62.2%). The scar count decrease from baseline was 21.7% at week 24 and 26.9% at week 48 on the half-face treated for 48 weeks with A0.3/BPO2.5. For the half-face treated with vehicle followed by 24 weeks' A0.3/BPO2.5, scar count increased by 16.7% at week 24 (under vehicle) and decreased by 22.7% between weeks 24 and 48. The half-face that received 48 weeks' A0.3/BPO2.5 had a lower final atrophic scar count (mean 8.4 vs. 9.9 for the half-face with 24 weeks' vehicle then 24 weeks' A0.3/BPO2.5) and a higher percentage of SGA clear/almost clear. High reductions in acne lesions between baseline and week 48 were observed for both sides of the face. Long-term treatment with A0.3/BPO2.5 was safe and well-tolerated., Conclusions: Reductions in atrophic acne scars and acne lesions observed after 24 weeks of treatment with A0.3/BPO2.5 gel were maintained with treatment up to 48 weeks. The additional improvement in atrophic scar count with 48 weeks' A0.3/BPO2.5 treatment, compared to delayed application at 24 weeks, highlights the importance of early initiation of effective acne treatment to prevent and reduce the formation of acne scars., Trial Registration: ClinicalTrials.gov identifier NCT02735421.

Background: Patients with skin of color (SOC) and Fitzpatrick skin types (FST) IV–VI frequently develop acne. Objective: Evaluate subject-reported outcomes after treatment with adapalene 0.3%/ benzoyl peroxide 2.5% gel (0.3% A/BPO) in subjects with SOC and moderate to severe acne vulgaris. Methods: This was an open-label interventional study conducted in 3 countries (Mauritius, Singapore, and USA) in subjects of Asian, Latin-American, or black/African-American ethnicity, with an Investigator’s Global Assessment (IGA) of moderate or severe facial acne (enrollment 2:1), and FST IV to VI. For 16 weeks, subjects applied 0.3% A/BPO (once daily) and utilized a skin care regimen (oil control foam wash and oil control moisturizer SPF30). Assessments included quality of life (QoL) and subject questionnaires, IGA, Investigator’s Global Assessment of Improvement (GAI), postinflammatory hyperpigmentation (PIH; if present at baseline), and safety. Results: Fifty subjects were enrolled: 20 Asians, 17 black/African-Americans, and 13 Latin-Americans. Most had FST IV (74%) or V (22%), with moderate (70%; IGA 3) or severe (30%; IGA 4) acne. At week 16, 77% of subjects were satisfied or very satisfied with treatment, 56% of subjects had an IGA of 0 or 1 (clear/almost clear), and 87% had a good to excellent improvement in GAI. QoL improved throughout the study for all subjects; subject selection of “no effect at all” of acne on QoL increased from 16% of subjects at baseline to 55% at week 16. Of those with baseline PIH (60%), all were rated very mild to moderate. By week 16, the majority (75%) had no or very mild PIH, and the mean decrease in PIH was 27%. There were no adverse events leading to study discontinuation. Conclusion: Patients with SOC and moderate or severe facial acne reported high satisfaction with 0.3% A/BPO treatment and experienced good tolerability, improved QoL, treatment efficacy, and improvement in PIH. Clinicaltrials.gov number: NCT02932267 J Drugs Dermatol. 2019;18(6):514-520.

The aim of this study was to evaluate the efficacy, safety, and tolerability of three formulations of DC161 oral spray, a saliva substitute, and a comparator in relieving drug-induced xerostomia. This was an open-label, randomized, 4-period, cross-over study in adult subjects with drug-induced xerostomia and documented hyposalivation. During each of the four 1-day periods, one product (one of three DC161 formulations or the comparator) was applied at T0 and then at T4h (before a meal). Mouth dryness and related symptoms were evaluated by the subject on a 100-mm visual analog scale. The primary efficacy criterion was the area under the curve of the dry mouth evaluation (baseline to T4h) after the first application. The oral mucosa was examined by a dental specialist; tolerability and product acceptability were assessed by the subject. Twenty-four subjects were randomized and completed the study. Despite large variability in data among the products, the selected aqueous formulation - DC161-DP0292 - reduced the intensity of dryness of mouth at least as well as the comparator; DC161-DP0292 provided a fast relief and a long-lasting effect on mouth dryness. Both products improved other symptoms such as swallowing and speaking, even when applied just prior to a meal. DC161-DP0292 was well tolerated and rated by subjects as providing a slightly higher acceptability of taste/aftertaste, texture, and lubricating effect than the comparator. No clinically relevant signs were reported for any product following the oral examination. DC161-DP0292 provides fast and long-acting symptomatic relief and is a relevant new treatment for drug-induced xerostomia.

Background: The treatment of various irritant dermatitis involves the elimination of the casual or favoring factor, the control of aggravating factors, and administration of topical agents. Even though corticosteroids are extensively used in these conditions to reduce the inflammation, it can also result in undesirable side effects. Hence, there is a need for a non steroidal topical agent to be used in these conditions., Aims: To evaluate the efficacy and tolerance of repairing cream RV 2427B in children and adults in irritant dermatitis care., Materials and Methods: In this phase III open labeled, multicenter, non-controlled, non-randomized trial, irritant dermatitis in children and adults either due to diaper rash, pityriasis alba and irritant dermatitis (eczema), perioral dermatitis, perleche or intertrigo were administered; repairing cream RV 2427 B containing a) 4 % zinc oxide, b) 2.5 % dry colloidal oat extract, (c) 0.5 % oat oil, (d) 0.2% copper sulfate, and (e) 0.1 % zinc sulfate to be applied twice-daily in the affected area. The subjects were evaluated on day 7 and day 21 for both efficacy and tolerance and last visit for cosmetic acceptability. The trial was conducted in accordance with the good clinical practices (GCP) after obtaining ethical clearance from respective Institutional Review Boards. Statistical evaluation was by variance analysis and student test for the quantitative variables, chi-square test for the qualitative variables., Results: Of the 136 enrolled subjects, 95 completed the study. After 21 days of treatment, 84% of the subjects assessed by the investigator and 76% by the self-assessment for the cream found effective. Investigational product was considered to be safe after 7 and 21 days of use., Conclusion: Repairing cream RV 2427 B is effective and safe in the management of irritant dermatitis.