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Background: Truncal acne is common and burdensome for patients; however, there is paucity of evidence and guidance for the management of truncal acne. Currently, clinical practice guidelines provide very little guidance on the assessment or management of truncal acne., Objectives: To identify unmet needs in truncal acne and make recommendations to address clinical and management gaps using an international consensus., Methods: The Personalising Acne: Consensus of Experts panel consisted of 13 dermatologists, who used a modified Delphi approach to reach a consensus on statements related to clinically relevant aspects of truncal acne evaluation and management. A consensus was defined as ≥75% of the panelists voting "agree" or "strongly agree." The voting was electronic and blinded., Results: The panel identified gaps and made recommendations related to truncal acne identification, assessment, and grading; the evaluation of the impact on patients; and treatment goals and factors to be considered for its management., Limitations: The recommendations are based on expert opinion, in the absence of high-quality evidence., Conclusions: We highlighted addressing not just facial acne but also truncal acne during patient consultations. The recommendations made herein may help facilitate the care of patients who present with truncal acne, with or without facial acne., Competing Interests: All panel members received honoraria from Galderma for participating in this project. Dr Tan has acted as an advisor, consultant, investigator, and/or speaker and received grants/honoraria from Bausch, 10.13039/501100009754Galderma, Pfizer, Almirall, Boots/Walgreens, Botanix, Cipher Pharmaceuticals, 10.13039/501100009754Galderma, Novan, Novartis, Promius, Sun Pharma, and Vichy. Dr Alexis has received grant/research support from LEO Pharma, 10.13039/100004336Novartis, Almirall, Bristol-Myers Squibb, Amgen, Menlo, 10.13039/501100009754Galderma, Valeant (Bausch Health), Cara, and Arcutis; has acted as a consultant for LEO Pharma, Novartis, Menlo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Unilever, Beiersdorf, Valeant, L'Oreal, Bristol-Myers-Squibb, Menlo, Scientis, Bausch health, UCB, Foamix, Cassiopea, Arcutis, Janssen, Allergan, Almirall, AbbVie, and Sol-Gel; and has acted as a speaker (unbranded) for Regeneron, SANOFI-Genzyme, Pfizer, and AstraZeneca. Dr Baldwin has acted as an investigator, consultant, and/or speaker for Almirall, Bausch, Cassiopea, EPI Health, Galderma, La Roche-Posay, L'Oreal, Mayne Pharma, Sol-Gel, Sun Pharma, and Vyne. Dr Beissert has acted as an advisory board member for AbbVie Deutschland GmbH & Co KG, Actelion Pharmaceuticals Deutschland GmbH, Amgen GmbH, Celgene GmbH, Galderma Laboratorium GmbH, Janssen-Cilag GmbH, LEO Pharma GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, MSD Sharp & Dohme GmbH, Menlo Therapeutics, Sanofi-Aventis Deutschland GmbH, Pfizer Pharma GmbH, and UCB Pharma GmbH and has received speaker honorarium from Novartis Pharma GmbH, AbbVie Deutschland GmbH & Co KG, MSD Sharp & Dohme GmbH, Pfizer Pharma GmbH, Janssen-Cilag GmbH, Galderma Laboratorium GmbH, Celgene GmbH, La Roche-Posay Laboratoire Pharmaceutique, Actelion Pharmaceuticals Deutschland GmbH, GlaxoSmithKline GmbH & Co KG, Bristol-Myers Squibb GmbH & Co KGaA, Sanofi-Aventis Deutschland GmbH, Almirall-Hermal GmbH, and Sandoz/HEXAL AG. Dr Bettoli has acted as a consultant, advisory board member, and research investigator and received honoraria from AbbVie, Baiersdorf, Bioderma, Biogena, Difa-Cooper, Galderma, GSK, ICF, LEO Pharma, L'Oreal, Meda, Menarini – Relife, Mylan, Novartis, Pharcos-Biodue, UCB Pharma and received research support (funds to institution) from AbbVie. Dr Rosso has acted as a research investigator, consultant, and/or speaker for Almirall, Bausch Health (Ortho Dermatology), BiopharmX, EPI Health, Galderma, LEO Pharma, Mayne Pharma, Sol-Gel, Sonoma, Sun Pharma, and Vyne Therapeutics (Foamix). Dr Dréno has acted as a consultant for Galderma. Dr Stein Gold has acted as an investigator/advisor and/or speaker for Galderma, Ortho Derm, Sun Pharma, Sol-Gel, Foamix, Novartis, and Almirall. Dr Harper has acted as a consultant for Almirall, BioPharmX, Cassiopea, Cutera, EPI, Foamix, Galderma, Ortho, Sol-Gel, and Sun Pharma. Dr Lynde has acted as a principal investigator, speaker, and consultant for Cipher Pharma, Bausch Health, Galderma, Johnson & Johnson, GSK, and Valeant. Dr Thiboutot has acted as a consultant for Cassiopea, Galderma, and Novartis. Dr Weiss has acted as an investigator/advisor and/or speaker for Galderma, Ortho Derm, Foamix, Novartis, Almirall, Dr. Reddy's, and EPI Health. Dr Layton has acted as an advisor or consultant, been a chief investigator for research (funded to institution), and/or received honoraria for unrestricted educational events from Galderma, La Roche-Posay, L'Oreal, Cipher, Proctor and Gamble, Almirall, GSK, and Origimm., (© 2021 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.)

Background: The physical sequelae of acne include erythema, hyperpigmentation, and scarring, which are highly burdensome for patients. Early, effective treatment can potentially limit and prevent sequelae development, but there is a need for guidance for and evidence of prevention-oriented management to improve patient outcomes., Objective: To identify unmet needs of acne sequelae and generate expert recommendations to address gaps in clinical guidance., Methods: The Personalizing Acne: Consensus of Experts panel of 13 dermatologists used a modified Delphi approach to achieve a consensus on the clinical aspects of acne sequelae. A consensus was defined as ≥75% of the dermatologists voting "agree" or "strongly agree." All voting was electronic and blinded., Results: The panel identified gaps in current guidance and made recommendations related to acne sequelae. These included identification and classification of sequelae, pertinent points to consider for patient consultations, and management aimed at reducing the development of sequelae., Limitations: The recommendations are based on expert opinion and made in the absence of high-quality evidence., Conclusions: The identified gaps should help inform future research and guideline development for acne sequelae. The consensus-based recommendations should also support the process of consultations throughout the patient journey, helping to reduce the development and burden of acne sequelae through improved risk factor recognition, early discussion, and appropriate management., Competing Interests: All panel members received honoraria from Galderma for participating in this project. Dr Layton has acted as an advisor or consultant, been a chief investigator for research (funded to institution), and/or received honoraria for unrestricted educational events from 10.13039/501100009754Galderma, La Roche-Posay, L'Oreal, LEO Pharma, Cipher, Proctor and Gamble, Almirall, GSK, and Origimm. Dr Alexis has received grant/research support from LEO Pharma, Novartis, Almirall, Bristol-Myers Squibb, Amgen, Menlo, 10.13039/501100009754Galderma, Valeant (Bausch Health), Cara and Arcutis; has acted as a consultant for LEO Pharma, Novartis, Menlo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Unilever, Beiersdorf, Valeant, L'Oreal, Bristol-Myers-Squibb, Menlo, Scientis, Bausch health, UCB, Foamix, Cassiopea, Arcutis, Janssen, Allergan, Almirall, AbbVie and Sol-Gel; and has acted as a speaker (unbranded) for Regeneron, SANOFI-Genzyme, Pfizer, and AstraZeneca. Dr Baldwin has acted as an investigator, consultant, and/or speaker for Almirall, Bausch, Cassiopea, EPI Health, Galderma, La Roche-Posay, L'Oreal, Mayne Pharma, Sol-Gel, Sun Pharma, and Vyne. Dr Beissert has acted as an advisory board member for AbbVie Deutschland GmbH and Co KG, Actelion Pharmaceuticals Deutschland GmbH, Amgen GmbH, Celgene GmbH, Galderma Laboratorium GmbH, Janssen-Cilag GmbH, LEO Pharma GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, MSD Sharp and Dohme GmbH, Menlo Therapeutics, Sanofi-Aventis Deutschland GmbH, Pfizer Pharma GmbH, and UCB Pharma GmbH and has received speaker honorarium from Novartis Pharma GmbH, AbbVie Deutschland GmbH and Co KG, MSD Sharp and Dohme GmbH, Pfizer Pharma GmbH, Janssen-Cilag GmbH, Galderma Laboratorium GmbH, Celgene GmbH, La Roche-Posay Laboratoire Pharmaceutique, Actelion Pharmaceuticals Deutschland GmbH, GlaxoSmithKline GmbH and Co KG, Bristol-Myers Squibb GmbH and Co KGaA, Sanofi-Aventis Deutschland GmbH, Almirall-Hermal GmbH, and Sandoz/HEXAL AG. Dr Bettoli has acted as a consultant, advisory board member, and research investigator; received honoraria from AbbVie, Baiersdorf, Bioderma, Biogena, Difa-Cooper, Galderma, GSK, ICF, LEO Pharma, L'Oreal, Meda, Menarini – Relife, Mylan, Novartis, Pharcos-Biodue, UCB Pharma; and received research support (funds to institution) from AbbVie. Dr Rosso has acted as a research investigator, consultant, and/or speaker for Almirall, Bausch Health (Ortho Dermatology), BiopharmX, EPI Health, Galderma, LEO Pharma, Mayne Pharma, Sol-Gel, Sonoma, Sun Pharma, and Vyne Therapeutics (Foamix). Dr Dréno has acted as a consultant for Galderma. Dr Gold has acted as an investigator or advisor and/or speaker for Galderma, Ortho Derm, Sun Pharma, Sol-Gel, Foamix, Novartis, and Almirall. Dr Harper has acted as a consultant for Almirall, BioPharmX, Cassiopea, Cutera, EPI, Foamix, Galderma, Ortho, Sol-Gel, and Sun Pharma. Dr Lynde has acted as a principal investigator, speaker, and consultant for Cipher Pharma, Bausch Health, Galderma, Johnson and Johnson, GSK, and Valeant. Dr Thiboutot has acted as a consultant for Cassiopea, Galderma, and Novartis. Dr Weiss has acted as an investigator or advisor and/or speaker for Galderma, Ortho Derm, Foamix, Novartis, Almirall, Dr. Reddy's, and EPI Health. Dr Tan has acted as an advisor, consultant, investigator, and/or speaker and received grants/honoraria from Bausch, 10.13039/501100009754Galderma, Pfizer, Almirall, Boots/Walgreens, Botanix, Cipher Pharmaceuticals, 10.13039/501100009754Galderma, Novan, 10.13039/100004336Novartis, Promius, Sun Pharma, and Vichy., (© 2021 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.)

Dermatologists are cognizant of the multiple clinical manifestations of rosacea, particularly persistent facial erythema, which has been deemed to be the most prevalent diagnostic feature and often poses a significant negative impact on quality of life. To address the need to recognize rosacea as a single disease with multiple potential phenotypes, a new classification system has been developed by 28 clinical and scientific experts worldwide.

Background: Acne vulgaris is a common skin disease that affects the face, chest, and back. While truncal acne is present in at least 50% of patients, clinical studies have focused predominantly on facial acne.1,2 Few treatments to date have been evaluated for truncal acne. Sarecycline is a narrow-spectrum, third-generation, tetracycline-class oral drug approved for the treatment of acne. Pivotal phase-3 studies show that sarecycline is safe, well-tolerated, and effective treatment for moderate to severe acne vulgaris., Method: Pooled analysis was performed for truncal acne results with sarecycline from the two phase 3 studies. Investigator Global Assessment (IGA) success was evaluated at weeks 3, 6, 9, and 12., Results: Chest IGA success rate were significantly greater with sarecycline versus placebo at weeks 3 (11.84% vs 7.71%, respectively; P=0.0192), 6 (18.81% vs 14.03%, respectively; P=0.0390), and 12 (33.42% vs 20.77%, respectively; P<0.0001). Back IGA success rate was also significantly greater with sarecycline versus placebo group at weeks 3 (12.13% vs 7.04%, respectively; P=0.0023), 6 (18.42% vs 14.34%, respectively; P=0.0412), 9 (29.05% vs 19.88%, respectively; P=0.0004) and 12 (33.07% vs 21.91%, respectively; P<0.0001)Conclusion: Sarecycline efficacy for truncal acne was observed within 3 weeks after treatment, supporting sarecycline as an optimal choice for oral treatment of moderate to severe truncal acne. J Drugs Dermatol. 2021;20(6):634-640. doi:10.36849/JDD.6204.

Since the US Food and Drug Administration (FDA) approved tretinoin in 1971, retinoids alone or combined with other agents have become the mainstay of acne treatment. Retinoids act through binding to retinoic acid receptors, altering expression levels of hundreds of cellular proteins affecting multiple pathways involved in acne pathogenesis. Retinoids have evolved from first-generation agents, such as tretinoin, through chemical modifications resulting in a second generation (etretinate and acitretin for psoriasis), a third generation (adapalene and tazarotene) and, most recently, a fourth (trifarotene). For all topical retinoids, local irritation has been associated with poor tolerability and suboptimal adherence. Efforts to improve tolerability have utilized novel delivery systems and/or novel agents. This qualitative literature review summarizes the evolution of the four topical single-agent retinoids available for the treatment of acne in the US today and their various formulations, presenting the rationale behind their development and data from key studies.

Since its approval in 1982, oral isotretinoin has revolutionized acne therapy. However, oral isotretinoin use has long been associated with challenges of variable bioavailability and food dependence. It is recommended to ingest oral isotretinoin with a high-fat meal in order to maximize absorption, but many patients fail to adhere to this recommendation. This may lead to inadequate isotretinoin absorption levels. Patients who fail to achieve isotretinoin target cumulative dose are more likely to experience symptom relapse. To address the challenge of traditional isotretinoin variable bioavailability, subsequent isotretinoin formulations have attempted to improve its absorption abilities. In 2014, an isotretinoin formulation utilizing Lidose technology, known as Absorica, showed significant improvements in absorption levels compared to traditional oral isotretinoin in the fasted state. In 2019, isotretinoin absorption levels were further advanced in a new formulation approved by the FDA known as Absorica LD. Utilizing advanced micronization technology that physically reduces the size of the drug molecule, Absorica LD exhibits twice the absorption levels of Absorica under fasting conditions. In the fed state, Absorica LD achieves similar plasma levels to Absorica with a 20 percent lower dose. Absorica LD also produces consistent serum isotretinoin levels irrespective of gastrointestinal contents. By eliminating the “food effect” seen in traditional oral isotretinoin, Absorica LD has the potential to improve patient adherence and long-term patient outcomes. J Drugs Dermatol. 20:5(Suppl):s5-11.

CLINICAL TRIALS ID: NCT02938494 BACKGROUND: In a Phase II study, tazarotene 0.045% lotion was statistically superior to vehicle and comparable to tazarotene 0.1% cream in reducing acne lesions, with fewer treatment-related adverse events (TEAEs) than the cream. OBJECTIVE: We analyzed data from the aforementioned study post-hoc to evaluate the effects of sex on treatment outcomes. METHODS: Participants aged 12 years or older with moderate-to-severe acne were randomized to tazarotene (0.045% lotion or 0.1% cream) or vehicle (lotion or cream) for 12 weeks of double-blind treatment. Outcomes analyzed in male and female subgroups included changes from baseline in inflammatory/noninflammatory lesions and TEAEs. RESULTS: In the intent-to-treat population (94 males and 116 females), reductions in lesion count were greater with tazarotene (lotion or cream) than with vehicle. In participants receiving tazarotene 0.045% lotion, the least-squares mean percent changes from baseline to Week 12 were greater in females than males, but the differences were not statistically significant (inflammatory [-70.3% vs. -56.2%]; noninflammatory [-60.0% vs. -53.2%]). In both females and males, the TEAE incidence was lower with tazarotene 0.045% lotion than 0.1% cream. CONCLUSION: Tazarotene 0.045% lotion substantially reduced acne lesions in both female and male participants. This newest tazarotene formulation might benefit patients who cannot tolerate older formulations or other topical retinoids. Given the relatively small size of this study, however, the results of this post-hoc analysis are intended to be exploratory in nature., Competing Interests: FUNDING:This study was sponsored by Ortho Dermatologics. DISCLOSURES:Dr. Baldwin has served as advisor, investigator, and on the speakers’ bureaus for Almiral, Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and Sun Pharma. Dr. Green has served as investigator, consultant, or speaker for Almirall, Cassiopea, Galderma, Ortho Dermatologics, Sol Gel, Sun Pharma, and Vyne. Dr. Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Dr. Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company. Ms. Forest and Dr. Pillai are employees of Bausch Health US, LLC, and may hold stock and/or stock options in its parent company. Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC., (Copyright © 2021. Matrix Medical Communications. All rights reserved.)

Our understanding of the pathogenesis of acne vulgaris is still evolving. It is known that multiple factors impact acne pathophysiology, including genetic, hormonal, inflammatory, and environmental influences. Because of its implications in many of these factors, diet has been a part of the acne discussion for decades. Several studies have evaluated the significance of the glycemic index of various foods and glycemic load in patients with acne, demonstrating individuals with acne who consume diets with a low glycemic load have reduced acne lesions compared with individuals on high glycemic load diets. Dairy has also been a focus of study regarding dietary influences on acne; whey proteins responsible for the insulinotropic effects of milk may contribute more to acne development than the actual fat or dairy content. Other studies have examined the effects of omega-3 fatty acid and γ-linoleic acid consumption in individuals with acne, showing individuals with acne benefit from diets consisting of fish and healthy oils, thereby increasing omega-3 and omega-6 fatty acid intake. Recent research into the effects of probiotic administration in individuals with acne present promising results; further study of the effects of probiotics on acne is needed to support the findings of these early studies. In this review, we discuss the current evidence regarding the diets of US patients with acne and how they may impact acne and acne treatment.

Acne vulgaris is the most common dermatological disease in the United States, affecting up to 85 percent of teenagers. While the American Academy of Dermatology has established guidelines regarding acne treatment in general, the variability among acne treatments, even within a given class, prevents establishment of a straightforward regimen. For example, moderate to severe acne is generally treated with an oral antibiotic, although several options are available-both across and within antibiotic classes. The aim of this review is to report the efficacy and safety data available for commonly prescribed oral antibiotics. While there are currently no data to support superiority of one drug over another, there are substantial differences in safety profiles and brand-specific features that may make one antibiotic preferable over another., Competing Interests: FUNDING:The development of this article was supported by an unrestricted grant from Journey Medical Corporation. DISCLOSURES:Dr. Baldwin serves on the speaker’s bureau, consults for, and/or attends medical advisory boards for Almirall, Galderma, Valeant Pharmaceuticals, Sun Pharmaceutical, Mayne Pharma, EPI Health, and Journey Medical Corporation., (Copyright © 2020. Matrix Medical Communications. All rights reserved.)

Introduction: Persistent facial erythema associated with rosacea may negatively impact quality of life (QoL), self-esteem, and self-confidence. We evaluated burden and health-related QoL (HRQoL) impacts of centrofacial erythema of rosacea., Methods: A cross-sectional, Web-based survey conducted in collaboration with the National Rosacea Society enrolled adults who self-reported having received a physician diagnosis of rosacea and self-evaluated their current erythema as mild to severe on the validated Subject Self-Assessment for Rosacea Facial Redness. Sociodemographic and clinical characteristics, rosacea symptoms, and their impacts on QoL [validated Impact Assessment for Rosacea Facial Redness (IA-RFR)] and HRQoL [validated Dermatology Life Quality Index (DLQI)] were recorded., Results: A total of 708 eligible respondents completed the survey (white/Caucasian, 93.5%; female, 83.1%; mean age, 52.4 years). Respondents had mild (59.2%), moderate (33.2%), or severe (7.6%) erythema. The most bothersome symptoms were persistent facial erythema (69.2%) and blushing/flushing (60.9%). Mean IA-RFR scores showed negative impacts across all severities of erythema. The mean (standard deviation) total DLQI score was 5.2 (6.0) overall [mild erythema, 3.8 (4.9); moderate, 5.7 (5.4); severe, 13.4 (8.9); P < 0.0001]., Conclusion: Centrofacial erythema of rosacea represents a substantial HRQoL burden, especially for those with more severe erythema., Funding: Allergan plc, Dublin, Ireland.

Background: A novel tretinoin 0.05% lotion formulation has been shown to be efficacious and well-tolerated, and especially effective in adult female acne patients. While it is perhaps counter-intuitive that patients with more severe disease would show clinically significant improvement with topical monotherapy, topical retinoids have been shown to offer realistic treatment options in these patients. Objective: To evaluate the safety and efficacy of once-daily tretinoin 0.05% lotion in adult females with moderate or severe acne. Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Adult females (>=18 years of age) with moderate (N=551) and severe (N=55) acne were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions, treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear) and quality of life (QoL) using the validated Acne-QoL questionnaire. Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout. Results: At week 12, efficacy in adult females with moderate acne (EGSS=3) treated with tretinoin 0.05% lotion was significantly greater than that reported with vehicle. Mean percent reduction in inflammatory and noninflammatory lesion counts was 58.5% and 55.5% respectively compared with 50.3% and 39.8% with vehicle (P=0.039 and P<0.001). Treatment success was achieved by 25.4% of subjects by week 12, compared with 15.4% with vehicle (P=0.006). Tretinoin 0.05% lotion was numerically more effective in adult females with severe acne (EGSS=4). Mean percent reduction in inflammatory and noninflammatory lesion counts was 59.0% and 58.8% respectively (compared with 53.5% and 45.5% with vehicle), and treatment success was achieved by 17.9% of subjects (compared with 4.5% with vehicle), with 46.6% of subjects achieving at least a 2-grade improvement in EGSS by week 12. Quality of life improvements with tretinoin 0.05% lotion were significant compared with vehicle in adult females with moderate acne (except role-social), but not in severe acne (probably due to the group size). The majority of AEs were mild and transient; more frequently reported in the moderate acne population where application site pain (2.9%), and application site dryness (5.0%) were the most common, compared with one report (4.5%) of application site pain and dryness in the severe acne population. Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by week 12. Limitations: The number of severe subjects enrolled in the studies was considerably less than the number of subjects with moderate acne, and the studies were not powered to demonstrate a difference in efficacy based on acne severity. Conclusions: Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in adult females with moderate acne, with notable improvements in treating adult females with severe acne. It was well-tolerated, and all treatment-related AEs were mild or moderate. J Drugs Dermatol. 2019;18(11):1147-1154.

Atrophic acne scarring is a frequent occurrence among acne patients. These facial marks are often very emotionally distressing for the patient and can result in adverse impact to quality of life. While most clinicians consider scarring as a sequela of moderate to severe acne, recent studies have found that scars are also associated with mild acne. Risk factors include time to effective treatment, severity of acne, family history, and excoriations. New data shows that early and effective acne treatment can reduce the development of new scars, confirming the widespread perception of this approach in prevention. It is also becoming clear that the inflammatory process drives both the development of acne lesions and atrophic scars. This implies that inhibiting activation of inflammatory pathways early is key to preventing scars. Data also suggests a useful role for adapalene for the treatment of well-established acne scars with scar remodeling accompanied by the production of new collagen and elastic tissue. Acne guidelines and recommendations continue to highlight the central role of retinoids, with fixed-dose combination retinoids being particularly important due to targeting of multiple inflammatory pathophysiologic factors and for patient convenience. Higher concentrations of retinoids such as adapalene 0.3%/benzoyl peroxide 2.5% (A0.3/BPO2.5) have shown increased efficacy, particularly among patients with moderately severe and severe acne – a population at high risk for scarring. Further, controlled study of A0.3/BPO2.5 in patients with moderate acne (mean, 40 acne lesions per half face) and mild-moderate scarring demonstrated A0.3/BPO2.5 was significantly superior to vehicle in reducing scar counts from baseline over 24 weeks. While scar counts lessened on the A0.3/BPO2.5 side, counts increased on the vehicle side during the study. This occurred in the setting of active acne, where the efficacy of A/BPO is well known, emphasizing the dual actions of A0.3/BPO2.5 in both treatment and prevention. J Drugs Dermatol. 2019;18(3):255-260.

Background: Acne vulgaris (acne) is a common dermatological condition typically associated with adolescents, affecting about 85% of young people. However, it is also prevalent and persistent into adulthood, particularly in females. The efficacy of tretinoin in acne is well documented with large pivotal studies. The first lotion formulation of tretinoin was developed to provide an important alternative option to treat acne patients who may be sensitive to the irritant effects of other tretinoin formulations. Objective: To determine whether efficacy and safety of tretinoin 0.05% lotion was similar in adolescent (<18 years) and adult (>=18 years) women with moderate-to-severe acne. Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Female subjects (aged 9 to 58 years, N=909) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout. Results: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts in female subjects were 56.9% and 51.7%, respectively, compared with 47.1% and 34.9% with vehicle (P=<0.001). Similar results were seen in adult and adolescent females in terms of reduction in inflammatory lesion counts with tretinoin 0.05% lotion; reduction in noninflammatory lesions was significantly greater in adult females (P=0.002). Treatment success was achieved by 23.6% of female subjects by week 12, compared with 13.5% on vehicle (P<0.001). Although treatment success was somewhat greater in adult females (24.6% versus 21.6%), the difference was not significant. The majority of AEs were mild and transient. There were five serious AEs (SAEs) reported (4/1, adult/adolescent, respectively). The most frequently reported treatment related AEs with tretinoin 0.05% lotion were application site pain (3.0%/5.7%), and application site dryness (4.9%/6.4%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by week 12. Slight increases in mean scores were observed for scaling, burning and stinging within the first four weeks and appeared to be transient. Conclusions: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in female acne. Noninflammatory lesion count reduction was significantly greater in adult females compared with adolescent females. The new lotion formulation was well-tolerated. J Drugs Dermatol. 2019;18(2):178-188.

Introduction: Acne vulgaris is more common in females than males and is challenging to treat. A post hoc analysis of 2 clinical trials evaluated the effect of dapsone gel, 7.5% based on sex and baseline acne lesion count. Methods: Two identically designed, randomized, double-blind, vehicle-controlled, multicenter, 12-week, phase 3 trials enrolled patients aged ≥12 years with facial acne and 20 to 50 inflammatory and 30 to 100 comedonal lesions. Patients applied dapsone gel, 7.5% or vehicle topically once daily for 12 weeks. Baseline to week 12 reductions were evaluated for total, inflammatory, and comedonal lesions in the pooled dapsone population by sex and total baseline acne lesion count (low: 50–74, medium: 75–99, and high: ≥100). Results: The analysis included 2160 patients (56% female, 44% male). Males and females had similar average baseline total, inflammatory, and comedonal lesion counts. Low, medium, and high subgroups experienced efficacy with dapsone gel, 7.5%. Females in each subgroup experienced superior efficacy to males. In females, total lesion counts in the low, medium, and high subgroups decreased by 56.07%, 50.22%, and 47.63%, respectively, compared with 47.95%, 42.30%, and 34.68% in males (P<0.001 for each male-female comparison). Females’ respective inflammatory lesion count percentage reductions were 60.96%, 57.91%, and 55.83%, versus 52.75% (P<0.001), 46.85% (P<0.001), and 44.70% (P=0.008) in males. Females’ respective comedonal lesion count percentage reductions were 52.96%, 45.40%, and 44.22%, versus 44.67% (P<0.001), 39.38% (P=0.030), and 29.89% (P=0.001) in males. The TEAE rate was low for the overall population (18.3%) and similar for females (19.0%) and males (17.4%). Males and females had similarly favorable dermal tolerability. Conclusion: Once-daily dapsone gel, 7.5% was efficacious for acne regardless of baseline total lesion count, with superior efficacy in females and similar tolerability in males and females. Registration identifier: Clinicaltrials.gov: NCT01974141 and NCT01974323

Introduction: Acne treatment guidelines suggest a combination approach with topical therapy including a topical retinoid, benzoyl peroxide and an oral antibiotic, or oral isotretinoin (OI), as first-line treatment options for severe acne vulgaris (AV). This study evaluated the efficacy and safety of a daily regimen of 0.3% adapalene and 2.5% benzoyl peroxide (0.3% A/BPO) gel and oral doxycycline 100 mg twice daily in severe (nonnodulocystic, non-conglobate) inflammatory AV., Methods: This was a phase 4, 12-week, single-arm, openlabel, multi-center investigational study. Subjects (males and females, 12 or older, with severe inflammatory AV, Investigator Global Assessment [IGA] 4, and less than equal to 4 nodulocystic lesions, n=186) were considered OI candidates at baseline by the investigator. OI candidacy was re-evaluated at each study visit. Efficacy endpoints included inflammatory lesion (IL) reduction (week 12), IGA success (defined as IGA 0 [Clear] or 1 [Almost Clear], weeks 4, 8, and 12), percent reduction in lesions (weeks 4, 8, and 12), and subject questionnaires (week 12). Safety assessments included adverse events (AEs) and tolerability., Results: Mean IL counts were significantly reduced from baseline to the end of the study (mean [SD]; baseline, 44.8 (21.73); week 12, 14.8 (16.11); mean percent reduction, 66.2% [30.47]; P less than .0001). By week 12, 37.1% of subjects achieved IGA Success (n=69, P less than .0001). Most subjects self-reported at least moderate improvement in AV (90.2%), and were "Satisfied" or "Very Satisfied" with the study treatment overall (83.2%). 41.9% of the subjects were no longer considered by their investigator to be OI candidates at week 4. At 12 weeks, only 19.9% were still considered OI candidates., Conclusion: 0.3% A/BPO + DOX is an effective and safe treatment option for severe inflammatory AV, before starting OI treatment, or as an alternative when OI cannot be used. ClinicalTrials.gov identifier: NCT02899000

J Drugs Dermatol. 2018;17(3):264-273.

Rosacea is a common chronic inflammatory disease affecting the facial skin whose etiology and pathophysiology are the subject of much investigation. Risk factors include genetic and environmental elements that may predispose individuals to localized inflammation and abnormal neurovascular responses to stimuli. Recent studies have introduced an array of systemic rosacea comorbidities, such as inflammatory bowel disease and neurologic conditions, that can be challenging to synthesize. We critically review the current data behind reported rosacea comorbidities and identify and highlight underrecognized physiologic mediators shared among rosacea and associated comorbidities. This information may be helpful in addressing patient questions about potential systemic implications of rosacea and can serve as a candidate platform for future research to understand rosacea and improve treatments., (Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Acne vulgaris (acne) is the most common skin disease we see in dermatology practice. Although rare in childhood, severe acne can affect up to 12% of the adolescent population. A chronic disease, it requires both aggressive management and effective maintenance strategies. Oral antibiotics, in combination with topical agents are recommended for treatment, with topical agents being continued as maintenance therapy to minimize resistance and recurrence. However, concerns with systemic side effects have recently resulted in a greater focus on the potential of fixed combination topical therapies to treat severe acne. Here we review the available clinical evidence. There are no studies investigating the use of fixed combination topical therapy exclusively in severe acne. However, studies assessing the treatment of moderate-to-severe acne include subpopulation data in severe patients. Adapalene 0.3%-benzoyl peroxide (BP) 2.5% was found to be effective in patients with severe acne, whereas the fixed combination with a lower concentration of adapalene (0.1%) was no more effective than vehicle. Clindamycin-BP 1.2%/3.75% gel and clindamycin-BP 1.2%/2.5% gel were both found to be effective in severe acne with an apparent BP-dose response. Clindamycin phosphate 1.2%-tretinoin 0.025% demonstrated similar efficacy in severe acne, but with little benefit over individual monads. Realistic topical treatment options now exist for the management of severe acne where patient and physician preference can impact positive outcomes.

J Drugs Dermatol. 2017;16(11):1134-1138.

Objective: Evaluate patients' perceptions of rosacea symptoms and treatments. Design: Cross-sectional, web-based survey conducted from May 8 to July 1,2015. Setting: E-mail invitation. Participants: Male and female adults in the United States who self-reported having a physician's diagnosis of rosacea. Measurements: Sociodemographic and clinical characteristics were collected for eligible respondents using the Self-Assessment of Rosacea Facial Redness scale and the Symptom Assessment for Rosacea Facial Bumps and Pimples questionnaire. Respondents were instructed how to differentiate erythematotelangiectatic rosacea and papulopustular rosacea. Use of different treatments and satisfaction with treatment were assessed, as were coping mechanisms. Results: More than 4,000 individuals responded and 600 completed the survey. The participants' mean age was 51.7 years and more than 90 percent rated their rosacea severity as mild or moderate. Most practiced stress and/or anxiety management, used makeup to cover rosacea, used sun protection, and changed their exercise regimens to cope with rosacea flare-ups. Participants reported avoiding sun exposure, hot baths and saunas, and specific skin care products to circumvent potential rosacea flare-ups. More than half (55.7%) had used a prescribed topical agent for rosacea in the preceding month, and 26.3 percent had used a prescribed oral antibiotic. Fewer than half were satisfied with treatment outcomes. Conclusion: Despite the chronic nature of rosacea, participants commonly used prescription agents only to treat flare-ups and relied on sun protection and other avoidance mechanisms to reduce their frequency. Education is needed to communicate the long-term nature of rosacea and the need for continued treatment to maintain long-term control., Competing Interests: Disclosure:This study was sponsored by Allergan plc, Dublin, Ireland. Manuscript preparation and editorial assistance was provided to the authors by Michael L. Pucci, PhD, of Peloton Advantage, Parsippany, New Jersey, and was funded by Allergan plc. Neither honoraria nor other form of compensation were made to the authors for authorship or any other activities related to preparation or submission of this manuscript. Related to the subject area of rosacea, Dr. Del Rosso serves as a consultant, speaker, and researcher for Allergan, Bayer Dermatology, and Galderma.

The skin is constantly exposed to various endogenous and exogenous factors that may impact its barrier function at the physical, mechanical, immunological, and microbial levels. These factors have the potential to initiate or exacerbate a variety of inflammatory skin conditions, especially those associated with barrier dysfunction. The barrier function of the skin depends upon a symbiotic relationship between resident microbial communities and host tissue. This symbiosis results from complex signals involved in both the innate and adaptive immune responses. Recent research indicates that both bacterial diversity and the relative abundance of different microbes present on and in the skin, may contribute to skin barrier stability or dysfunction. The objectives of this review are to discuss the relationship between the skin microbiota and skin barrier function and to consider mechanisms that may help its preservation. J Drugs Dermatol. 2017;16(1):12-18..

Stratum corneum (SC) abnormalities are associated with disease-affected skin conditions such as inflammatory acne. Current topical acne treatment options including benzoyl peroxide and retinoids can worsen the barrier dysfunctions by increasing transepidermal water loss, depleting SC vitamin E levels, and relatively decreasing SC thickness. However, strategies exist to employ these treatments in a more effective manner and lessen barrier function disruption including use of less irritating vehicles or concomitant application of moisturizers. Patients also play a role in the outcome of their skin barrier function based on their compliance and administration technique. By increasing patient compliance and proper application of treatments, patient skin barrier function can improve. Additionally, future treatments are on the horizon that may customize acne therapy at a molecular level. , , J Drugs Dermatol. 2016;15(10):1170-1173.

Most patients with acne have a disease that responds to acute treatment and can be controlled long term with a maintenance regimen of topical therapy. It is the minority of patients-generally, but not exclusively-the most severely affected, who respond poorly to acute therapy and require continued systemic therapy. The goals of therapy are resolution of visible lesions, prevention of new lesions, avoidance of scarring, and improvement of patient quality of life. Treatment choices are made on the basis of lesion type, number, and size, with consideration given to the presence of physical and psychological scarring. Semin Cutan Med Surg 34(supp5):S82-S85., (2015 published by Frontline Medical Communications.)

Background: Limited data are available on acne treatment patterns in females through their adult years., Objective: The purpose of this analysis was to evaluate health care resource utilization (HRU) and treatment patterns in cohorts with and without the use of acne medication and predictors of use., Methods: A cross-sectional, web-based survey was administered to US females (25-45 years) with facial acne (≥ 25 visible lesions). Data collected included: sociodemographics and self-reported clinical characteristics, acne treatments, and health care professional (HCP) visits. Subject characteristics associated with medication use were examined by logistic regression., Results: Approximately half of the total sample (N=208, mean age: 35 ± 6) ever visited an HCP for acne and reported more over-the counter (OTC) medication use (51.0%) than prescription (Rx) medication use (15.4%). Subjects did not use medications daily, averaging from 12-18 days over the previous 4 weeks. Logistic regression showed that race and prior HCP visits for acne were significant predictors of medication use (P<.05)., Conclusions: Adult females generally self-treated their acne using primarily OTC medications; however, poor compliance was observed for Rx and OTC. Race and prior HCP visits for acne were significant predictors of current medication use.

Rosacea is a condition most commonly characterized by central facial erythema and pupulopustules. There are highly effective drugs, both oral and topical, for papulopustular disease. At the present time, consistently effective pharmacologic therapy for erythematotelangiectatic rosacea is lacking. Patients whose papulopustular disease has been adequately treated are often still bothered by central facial erythema for which there is no adequate treatment short of laser and light. We present a study utilizing a novel topical composition evaluated for its ability to reduce background erythema remaining after adequate care of papulopustular disease. Patient, investigator and photographic evidence of erythema reduction was seen in 24/25 patients in this 8-week study.

Topical tretinoin has been approved for use in dermatology for 40 years and is currently approved for the treatment of acne vulgaris and photodamage. During this time, topical tretinoin has accumulated significant efficacy and safety data in the treatment of acne and photodamaged skin and demonstrated clinical potential for treating a range of other dermatologic conditions. The diverse effects may be due to complex underlying mechanisms of action associated with tretinoin, including keratolytic activity, collagenesis, and other mechanisms associated with the activation of nuclear retinoic acid receptors (RARα, RARβ, and RARγ). In this article, we review the history of topical tretinoin use to date and outline emerging research suggesting that topical tretinoin may have potential clinical use for treating a multitude of other dermatological conditions when used either as monotherapy or in combination with other agents. We also describe newer formulations of topical tretinoin that have been designed to reduce irritation potential. In light of the substantial history of safety and efficacy of topical tretinoin in acne and photodamage, we speculate that it holds promise in treating many additional dermatological conditions, which may be explored in future research.

Rosacea is a common disorder that is both under recognized and undertreated. Prevalence figures indicate that it may be present in 1 of every 10 adults in a primary care waiting room. Untreated, patients with rosacea can suffer significant emotional, workplace, and social impairments. While rosacea has been recognized since ancient times, only recently have investigators begun to identify the pathophysiologic elements responsible for the characteristic erythema, flushing, dysesthesias, and papulopustular manifestations of the disease. Although the etiology of rosacea is unclear, inflammation appears to be a central element. Experimental evidence suggests that abnormalities of the skin's innate and adaptive immune responses may play pivotal roles. Once recognized, effective topical and systemic therapies can be prescribed to lessen the impact of the disease on the patient's life. Although initially administered in an empiric fashion, it now seems clear that the role of antibiotics in patients with rosacea depends upon their anti-inflammatory rather than their antimicrobial properties. Consequently, practitioners have the opportunity to practice good antibiotic stewardship when treating the disease, particularly with systemic therapies. Therapy with subantimicrobial dosing and with topical treatments can modulate the inflammation of rosacea without exerting antibiotic pressure responsible for the emergence of antibiotic resistance.

The pathophysiology of rosacea has undergone renewed interest over the past decade, with a large body of evidence supporting the role of an abnormal innate immune response in rosacea. Many mechanisms interact with the cutaneous innate immune system that may be operative. A variety of potential triggers stimulate this immune detection system which is upregulated and hyper-responsive in facial skin of patients with rosacea as compared to normal skin. Based on the most current data, two conclusions have been reached. First, the major presentations of rosacea appear to be inflammatory dermatoses. Second, the presence of a microbial organism is not a primary or mandatory component of the pathogenesis of rosacea. Available therapies for rosacea exhibit reported modes of action that appear to correlate with the inhibition of inflammatory processes involved in the pathophysiology of at least some presentations of rosacea.

Changes to the skin of the face in patients with rosacea have the potential to substantially impair multiple domains of quality of life (QOL); however, the number of publications providing evidence for this topic is limited. This 12-week, open-label, community-based, phase 4 trial of 1421 participants is the largest study of the disease to date. It explores the effects of mild to severe rosacea and its treatment on QOL. Participants were treated with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) as monotherapy or add-on treatment to existing topical therapy. This article examines QOL issues in the primary analysis population consisting of 966 participants who completed the trial without a major protocol violation. Quality of life was assessed at baseline and study end (week 12) with the RosaQoL, a validated 21-question instrument. Participant and investigator satisfaction with treatment also were evaluated. In the monotherapy group, the mean RosaQoL score was 3.3 at baseline and 2.8 at end of study. In the add-on therapy group, the mean RosaQoL score was 3.2 at baseline and 2.8 at end of study. The improvement in QOL was both clinically and statistically significant (P < .0001) and was similar in both monotherapy and add-on therapy groups. Most participants expressed satisfaction with treatment and approximately 90% of the community-based investigators reported that they were likely or very likely to continue prescribing this formulation. The study demonstrates that the impaired QOL in patients with rosacea can be substantially improved during a 3-month period by once-daily treatment with the anti-inflammatory activity of subantimicrobial-dose doxycycline.

During fall 2008, 10 roundtable discussions involving 70 practicing dermatologists and a physician assistant were conducted across the United States to address patient considerations and treatment strategies for acne vulgaris. A case study format was used to initiate discussion. This supplement is based on the issues raised during the roundtable discussions and at a final working session among the authors where suggestions, trends, and the consensus from each of the 10 roundtable discussions were reviewed regarding published, evidence-based recommendations for treating acne vulgaris. Effective treatment of acne vulgaris can prevent adverse emotional sequelae and physical scarring. We hope that the information presented herein will help guide our colleagues in improving the care of patients with acne vulgaris.

Acne is the most common problem that presents to dermatologists. Because it causes visible disfiguring of the face, it produces a great deal of embarrassment, frustration, anger, and depression in patients. In addition, acne is most common in adolescence and young adulthood, a time when patients are least capable of coping with additional stress. As a result, it is virtually impossible to separate acne from psychiatric disturbances. Some patients are severely affected and require more than just acne therapy. Dermatologists need to become more adept at diagnosing and treating causative, concomitant, and resultant psychiatric disturbances in patients with acne. This article is intended to highlight the scope of the problem, identify at-risk patients, and help dermatologists assist patients with both their acne and their psychologic response to it.