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Acne prevalence may be higher in overweight/obese individuals, potentially due to hormonal, inflammatory, and/or dietary factors. However, the effects of body mass index (BMI) on topical acne treatments are largely unknown.Post hoc analyses of changes in inflammatory/noninflammatory lesions and treatment success were conducted using phase 3 data: clindamycin phosphate/benzoyl peroxide (CP/BPO) 1.2%/3.75% gel (NCT01701024); tretinoin 0.05% lotion (NCT02965456 and NCT02932306; pooled); and tazarotene 0.045% lotion (NCT03168321 and NCT03168334; pooled). Data were analyzed by BMI subgroups:25kg/mAmong participants analyzed (CP/BPO = 495; tretinoin = 1,636; tazarotene = 1,612), ∼20-25% were overweight and 15-20% were obese. At week 12, mean percent changes from baseline in inflammatory lesions were: CP/BPO (overweight: -63.2%, obese: -56.0%); tretinoin (-57.6%, -53.1%); tazarotene (-59.9%, -56.8%). Mean changes in noninflammatory lesions were: CP/BPO (-54.2%, -50.8%); tretinoin (-51.6%, -44.9%); tazarotene (-56.7%, -54.6%). Treatment success rates with active treatment ranged from 16.2% to 33.5% across BMI groups.CP/BPO 1.2%/3.75% gel, tretinoin 0.05% lotion, and tazarotene 0.045% lotion were all effective in reducing acne lesions by ≥45% in overweight/obese patients with moderate-to-severe acne, comparable to the underweight-to-normal group. Efficacy of these topical acne treatments is not greatly impacted by BMI and may be affected more by the formulation.

ImportanceCurrent topical treatment options for seborrheic dermatitis are limited by efficacy and/or safety.ObjectiveTo assess safety and efficacy of roflumilast foam, 0.3%, in adult patients with seborrheic dermatitis affecting the scalp, face, and/or trunk.Design, Setting, and ParticipantsThis multicenter (24 sites in the US and Canada) phase 2a, parallel group, double-blind, vehicle-controlled clinical trial was conducted between November 12, 2019, and August 21, 2020. Participants were adult (aged ≥18 years) patients with a clinical diagnosis of seborrheic dermatitis for a 3-month or longer duration and Investigator Global Assessment (IGA) score of 3 or greater (at least moderate), affecting 20% or less body surface area, including scalp, face, trunk, and/or intertriginous areas. Data analysis was performed from September to October 2020.InterventionsOnce-daily roflumilast foam, 0.3% (n = 154), or vehicle foam (n = 72) for 8 weeks.Main Outcomes and MeasuresThe main outcome was IGA success, defined as achievement of IGA score of clear or almost clear plus 2-grade improvement from baseline, at week 8. Secondary outcomes included IGA success at weeks 2 and 4; achievement of erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; achievement of scaling score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; change in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline; and WI-NRS success, defined as achievement of 4-point or greater WI-NRS score improvement in patients with baseline WI-NRS score of 4 or greater. Safety and tolerability were also assessed.ResultsA total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) or vehicle foam (n = 72). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the vehicle group (P P Conclusions and RelevanceThe results from this phase 2a randomized clinical trial of once-daily roflumilast foam, 0.3%, demonstrated favorable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis, supporting further investigation as a nonsteroidal topical treatment.Trial RegistrationClinicalTrials.gov Identifier: NCT04091646

Background A three-pronged approach to acne treatment—combining an antibiotic, antibacterial, and retinoid—could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance. Objectives We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne. Methods In a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed. Results A total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8–30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6–26.8; noninflammatory, 21.8–30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity. Conclusions Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne. Clinical Trial Registration ClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017). Supplementary Information The online version contains supplementary material available at 10.1007/s40257-021-00650-3.

Background The skin of neonates and infants undergoes a maturation process from birth and is susceptible to barrier disruption. The current algorithm follows a US-based consensus paper on skincare approaches using gentle cleansers and moisturizers in neonatal and healthy infant skin. This summary provides clinical information for pediatric dermatologists, dermatologists, and pediatric healthcare providers treating neonates and infants. Methods The project used a modified Delphi process comprising virtual discussions followed by an online follow-up replacing the use of a questionnaire. During the virtual meeting, the systematic literature review results and a draft algorithm addressing over-the-counter skincare for neonates and infants with healthy skin were discussed and adopted using evidence coupled with the expert opinion and experience of the panel. Results The algorithm addresses three clinical signs: xerosis, erythema, and erosion/bulla. A growing body of evidence recognizes the benefits of ongoing daily use of non-alkaline cleansers and ceramides containing moisturizers to reduce inflammation and maintain a healthy skin barrier function. Diaper rash is common in infants presenting as erythema or, in more severe cases, skin erosion. Skin protection with a barrier cream and frequent diaper changes using disposable diapers resolves most cases; however, if the rash continuous despite appropriate care, rule out a candida infection. Conclusion The current algorithm focuses on neonatal and infant healthy skin that can benefit from skincare. When applied from birth onwards, gentle cleansers and moisturizers containing barrier lipids help maintain the protective skin barrier. J Drugs Dermatol. 2021;20(11):1195-1205. doi:10.36849/JDD.6219.

Excessive sebum production is a factor in acne development. Tazarotene 0.045% lotion has demonstrated reductions in acne lesions and acne-induced sequalae.Evaluate efficacy, changes in skin oiliness, and safety with tazarotene 0.045% lotion in participants with moderate-to-severe acne and oily skin.In two phase 3, double-blind, 12-week studies (NCT03168321; NCT03168334), participants aged ≥9 years with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene 0.045% lotion or vehicle lotion (N = 1,614). This pooled, post hoc analysis included only participants self-categorized with oily skin at baseline on the Acne Quality of Life questionnaire item 19 (scores: 0 [extremely oily] to 6 [not at all oily]). Inflammatory/noninflammatory lesion counts, treatment success, skin oiliness, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were evaluated.In all participants with oily skin (n = 793), tazarotene provided greater reductions in inflammatory/noninflammatory lesions (iP/i lt; 0.001, both) and greater treatment success rates versus vehicle (iP/i lt; 0.01) at week 12. Over two-thirds of polymeric lotion-treated participants had subjective skin oiliness reductions by week 12, with around a third reporting 'low/not' oily skin. Tazarotene TEAE rates were similar to the overall population.Once-daily treatment with tazarotene 0.045% polymeric emulsion lotion may help improve patient-perceived skin oiliness in those with moderate-to-severe acne.

Background Topical retinoids are recommended for acne treatment, but their use may be limited by irritation or dermatitis. Herein is an overview of the dermal sensitization, safety, tolerability, and participant satisfaction data from phase-1, -2, and -3 studies of lower-dose tazarotene 0.045% polymeric emulsion lotion. Methods Two phase-1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase-2 (NCT02938494) and two phase-3 studies (NCT03168334; NCT03168321) were double-blind, randomized, and vehicle-controlled over 12 weeks in participants aged ≥9 years (≥12 years, phase-2) with moderate-to-severe acne. Results A total of 2029 participants (tazarotene 0.045% lotion or vehicle) were included across the 5 studies (safety populations: n = 1982). In the phase-1 studies, tazarotene had a low potential for irritancy/contact dermatitis and did not induce sensitization. In all studies, tazarotene lotion was well tolerated and had a positive safety profile. In addition, tazarotene lotion reduced the severity of hyperpigmentation and erythema and participants preferred it more than previous acne treatments. Conclusions The results from these five studies show that the tolerability, safety, and patient satisfaction of topical tazarotene 0.045% lotion, combined with its efficacy, make it an important option for the treatment of acne.

The Psoriasis Area and Severity Index (PASI) is the most widely used clinical measure in clinical trials to assess disease severity of plaque psoriasis. However, the PASI is not a precise measure of severity with less precision when the regional area of involvement is

Psoriasis is polygenic, interleukin (IL)-17 and IL-23 driven chronic relapsing inflammatory multisystem disease caused by a complex interplay of endogenous and environmental factors. The most common and distressing symptom in psoriasis is itch, adding significantly to the burden of disease. Although histamine has historically not been considered a key itch mediator in psoriasis, there is some evidence from the literature that antihistamines may be effective to reduce itch in psoriasis. This review focuses on the role of antihistamines in the management of itch in psoriasis. The literature search included peer-reviewed articles published in English language (clinical trials or scientific reviews). Studies were identified by searching electronic databases (MEDLINE and PubMed) until January 2021 and by reference lists of respective articles. J Drugs Dermatol. 2021;20(8):844-847. doi:10.36849/JDD.5966.

Introduction: Increased circulating androgens are key to the multifactorial pathogenesis of acne. Clascoterone is the first topical androgen antagonist developed to treat acne in both male and female patients and the first such agent to receive U.S. Food and Drug Administration (FDA) approval for treatment of acne. Androgens directly stimulate sebaceous gland growth and increased sebum production, creating a nourishing medium in which anaerobic Cutibacterium acnes (C. acnes) bacteria flourish. Androgens may directly contribute to inflammation in the sebaceous gland.Areas covered: In this review, the author assesses clascoterone's potential role in the management of acne. With a 4-ring backbone identical to dihydrotestosterone (DHT) and spironolactone, topically applied clascoterone binds androgen receptors (ARs) in the sebaceous glands and hair follicles, interfering with the pathogenesis of acne and reducing acne lesions with no reported systemic effects.Expert opinion: Phase III study results confirmed the safety and efficacy of topical clascoterone for acne, with considerable reductions in absolute non-inflammatory and inflammatory lesion counts at week 12. The approval of a first-in-class topical androgen antagonist is indeed a 'game-changer' for acne management. This topical agent is expected to be quickly adopted in clinical practice, likely within combination regiments, yet to be formally evaluated.

Psoriasis is a chronic disease requiring long-term treatment strategies. Optimal strategies should include initial rapid relief of symptoms followed by long-term management to maintain remission. This 4-week open-label phase of a long-term proactive management phase 3 trial aimed to select responders to once daily, fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis and assess patient-reported outcomes.This phase 3 trial in adults with psoriasis included a 4-week open-label lead-in phase to determine treatment success prior to entering the randomized maintenance phase. Success was defined as Physician Global Assessment (PGA) scorelsquo;clearrsquo;/lsquo;almost clearrsquo; (PGAlt;2) withge;2-grade improvement from baseline. Those achieving treatment success at week 4 entered the maintenance phase; non-responders were withdrawn from the trial.650 patients enrolled in the open-label phase, and 623 were treated with Cal/BD foam for 4 weeks; 521 (80%) patients achieved treatment success and were included in the maintenance phase. In those patients achieving success (responders), 21.1% and 78.9% achieved a PGA score oflsquo;clearrsquo; andlsquo;almost clearrsquo;, respectively. Mean change from baseline in modified Psoriasis Area and Severity Index (plusmn; standard deviation [SD]) and body surface area (plusmn; SD) in responders at week 4 wasminus;82.1% (16.4%) andminus;56.6% (38.3%), respectively. Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521). 17.7% of patients experienced AEs; with only one severe AE reported.Cal/BD foam was highly efficacious and well tolerated during the 4-week lead-in phase of PSO-LONG. J Drugs Dermatol. 2021;20(4):436-441, doi:10.36849/JDD.5728.

Introduction: Psoriasis, an immune-mediated disease that manifests cutaneously with possible arthritic complications, affects millions of people in the United States and worldwide. Depression and suicidal ideation and behavior (SIB) are two prevalent comorbidities associated with psoriasis, due to the chronic nature of the disease, lack of a cure, as well as social stigma, all of which are detrimental to quality of life. Among the options available for management of moderate-severe psoriasis, apremilast and brodalumab represent recent additions to the therapeutic armamentarium for managing psoriasis. It has been suggested that the aforementioned drugs can lead to depression and possibly increase the risk for SIB. Furthermore, a black box warning was issued for brodalumab. This review challenges opinions that the drugs are solely responsible for exacerbating depression and SIB, when in fact it could be psoriasis itself. Methods: An extensive search of available literature linking cytokines to suicidal behavior was performed. After filtering for relevance, 22 articles were reviewed in detail. Results: Brodalumab and apremilast, both molecularly and clinically, do not objectively increase the risk for depression and/or suicidal ideation and behavior. Conclusion: After careful review of the appropriate studies and relevant literature, patients with moderate-severe psoriasis, including those that experience depression resulting from their chronic condition, would likely benefit from early, rather than delayed initiation of effective medications like apremilast and brodalumab. The speed of response and high level of efficacy of brodalumab make it an ideal intervention for patients suffering depression caused by their psoriasis.

Objective To provide guidance about management of psoriatic disease during the COVID-19 pandemic. Study Design A task force (TF) of 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care was convened. The TF was supplemented by non-voting members which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by questions received by the NPF. A Delphi process was conducted. Results The TF approved 22 guidance statements. The average of the votes was within the category of agreement for all statements. All guidance statements proposed were recommended, 9 with high consensus, 13 with moderate consensus. Limitations The evidence behind many guidance statements is limited in quality. Conclusion These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk and outcome, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with SARS-CoV-2 and what they should do if they develop COVID-19. The guidance is intended to be a living document that will be updated by the TF as data emerge., Capsule Summary The NPF COVID-19 Task Force produced 22 guidance statements to promote optimal management of psoriatic disease during the pandemic. Shared decision making is recommended as is adherence to evidence-based recommendations when available. The guidance statements will be updated when necessary in accordance with rapidly evolving science of COVID-19.

Background Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks. Objective The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects. Methods Once-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach. Planned Outcomes Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic–pituitary–adrenal axis function. Trial registration ClinicalTrials.gov identifier, NCT02899962. Electronic supplementary material The online version of this article (10.1007/s12325-020-01497-6) contains supplementary material, which is available to authorized users.

Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis.In this phase 2b, double-blind trial, we randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.3% cream, roflumilast 0.15% cream, or vehicle (placebo) cream once daily for 12 weeks. The primary efficacy outcome was the investigator's global assessment (IGA) of a status of clear or almost clear at week 6 (assessed on a 5-point scale of plaque thickening, scaling, and erythema; a score of 0 indicates clear, 1 almost clear, and 4 severe). Secondary outcomes included an IGA score indicating clear or almost clear plus a 2-grade improvement in the IGA score for the intertriginous area and the change in the Psoriasis Area and Severity Index (PASI) score (range, 0 to 72, with higher scores indicating worse disease). Safety was also assessed.Among 331 patients who underwent randomization, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream. An IGA score indicating clear or almost clear at week 6 was observed in 28% of the patients in the roflumilast 0.3% group, in 23% in the roflumilast 0.15% group, and in 8% in the vehicle group (P0.001 and P = 0.004 vs. vehicle for roflumilast 0.3% and 0.15%, respectively). Among the approximately 15% of patients overall who had baseline intertriginous psoriasis of at least mild severity, an IGA score at week 6 indicating clear or almost clear plus a 2-grade improvement in the intertriginous-area IGA score occurred in 73% of the patients in the roflumilast 0.3% group, 44% of those in the roflumilast 0.15% group, and 29% of those in the vehicle group. The mean baseline PASI scores were 7.7 in the roflumilast 0.3% group, 8.0 in the roflumilast 0.15% group, and 7.6 in the vehicle group; the mean change from baseline at week 6 was -50.0%, -49.0%, and -17.8%, respectively. Application-site reactions occurred with similar frequency in the roflumilast groups and the vehicle group.Roflumilast cream administered once daily to affected areas of psoriasis was superior to vehicle cream in leading to a state of clear or almost clear at 6 weeks. Longer and larger trials are needed to determine the durability and safety of roflumilast in psoriasis. (Funded by Arcutis Biotherapeutics; ARQ-151 201 ClinicalTrials.gov number, NCT03638258.).

Background: Neonates and infants are susceptible to skin barrier disruption as their skin anatomically and functionally is still developing. The process of skin acidification plays a vital role in barrier maturation and the activation of enzymes involved in the extracellular processing of stratum corneum lipids. The current consensus paper explores challenges, and current treatment approaches in neonatal and infant normal and sensitive skin and the role of ceramides containing moisturizers. Methods: For this purpose, an expert panel of pediatric dermatologists and dermatologists discussed information from systematic literature searches, coupled with expert opinion and experience of the panel, to adopt eight statements. The consensus process consisted of a modified Delphi technique. Results: During the first years after birth, the neonatal and infant skin is more permeable to topical agents and, therefore, requires particular caution with topical skincare regimens. Mildly acidic or pH-neutral cleansers have benefits for neonates and infants. Skincare for neonates and infants should be safe, effective, and fragrance free as well as sensitizing agent-free. Additionally, the skincare should be pleasant to use, containing ingredients that benefit the lipid and water content of the SC, such as those products containing ceramides. Conclusion: Taking into consideration the maturation process of neonatal and infant skin, the application of moisturizers and cleansers containing barrier lipids may help maintain the protective skin barrier and soothe with long-term moisturizing benefits. J Drugs Dermatol. 2020;19(8) 769-776: doi:10.36849/JDD.2020.5252 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery.To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea.Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea.Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred.The generalizability of these data from a controlled clinical trial should be examined in a real-world setting.FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.

Psoriasis patients with comorbid depression represent a common therapeutic challenge for dermatologists. Depressed patients often require the practicing dermatologist to go outside of their comfort zone, and the FDA’s labeling of medications such as brodalumab have further complicated an already difficult-to-treat patient population. A multi-disciplinary work-group consisting of a board-certified psychiatrist, a licensed clinical psychologist, and multiple dermatologists was convened to formulate practical recommendations for the evaluation and treatment of this at-risk population. How to broach the subject of depression and when to refer patients for formal evaluation were discussed. The expert panel also produced a consensus statement regarding the use of brodalumab in patients with both psoriasis and depression.

Up to 80% of individuals with plaque psoriasis have scalp involvement, which can have a significant impact on the quality of life of affected individuals. Despite advancements in psoriasis therapeutics, management of scalp involvement remains a challenge. This12-week, open-label pilot study assessed the safety and efficacy of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion for the treatment of patients with mild-to-moderate plaque psoriasis with scalp involvement. Among 20 patients who were followed through 12 weeks, there were significant improvements in the primary endpoint (Investigatorrsquo;s Global Assessment (IGA)) and most secondary endpoints (Psoriasis Scalp Severity Index (PSSI), body surface area (BSA), and scalp IGA (sIGA)). Treatment was well-tolerated. Further placebo-controlled double-blinded study for confirmation of our results is recommended. J Drugs Dermatol. 2021;20(11): 1191-1194. doi:10.36849/JDD.0102.

Topical agents for actinic keratosis (AK), along with cryotherapy and phototherapy, are the most commonly used therapies for areas of skin with multiple AKs. Multiple options for the topical treatment of AK exist; newer therapies aim to balance efficacy with an acceptable safety and tolerability profile for the patient.To describe the safety and tolerability of FDA-approved topical agents for the treatment of AK.A systematic review of phase III clinical trials of topical agents for AK available on PubMed and clinicaltrials.gov was conducted on January 10th, 2021.29 phase III clinical trials meeting the inclusion criteria were included in the qualitative synthesis. No serious adverse events or systemic adverse events were determined to be due to topical therapies for AK. The highest rates of treatment-related application-site adverse events and local skin reactions occurred with the various formulations of topical 5-FU and imiquimod; newer topical agents such as ingenol mebutate and tirbanibulin had more favorable tolerability profiles.FDA-approved topical agents for the treatment of multiple AKs have minimal safety concerns. Tolerability profiles vary among the available options, and new agents such as tirbanibulin offer a favorable combination of safety, tolerability, and efficacy. J Drugs Dermatol. 2021;20:10(Suppl):s4-11.

ImportanceOnce-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.ObjectiveTo evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis.Design, Setting, and ParticipantsTwo phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively.InterventionsPatients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks.Main Outcomes and MeasuresThe primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points).ResultsAmong 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P P P P Conclusions and RelevanceAmong patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety.Trial RegistrationClinicalTrials.gov Identifiers: NCT04211363, NCT04211389

Psoriasis is a chronic and debilitating inflammatory immune-mediated skin disorder. Several cytokines including interleukin (IL)-23 were demonstrated to play a central role in the pathogenesis of this disease. Treatment options for psoriasis range from topical to systemic modalities, depending on the extent, anatomical locations involved and functional impairment level. Targeting cytokines or their cognate receptors that are involved in disease pathogenesis such as IL-12/23 (i.e., targeting the IL-12p40 subunit shared by these cytokines), IL-17A, IL-17F, IL-17RA, and TNF-α using biologic agents emerged in recent years as a highly effective therapeutic option for patients with moderate-to-severe disease. This review provides an overview of the important role of IL-23 signaling in the pathogenesis of psoriasis. We describe in detail the available IL-23 inhibitors for chronic plaque psoriasis. The efficacy, pharmacokinetic properties, and the safety profile of one of the most recent IL-23 biologic agents (tildrakizumab) are evaluated and reviewed in depth.

Objective To update guidance regarding the management of psoriatic disease during the COVID-19 pandemic. Study Design The task force (TF) includes 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care. The TF was supplemented by non-voting members, which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by inquiries received by the NPF. A Delphi process was conducted. Results The TF updated evidence for the original 22 statements and added 5 new recommendations. The average of the votes was within the category of agreement for all statements, 13 with high consensus, 14 with moderate consensus. Limitations The evidence behind many guidance statements is variable in quality and/or quantity. Conclusion These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with SARS-CoV-2 (including novel vaccination), and what they should do if they develop COVID-19. The guidance is a living document that is continuously updated by the TF as data emerge., Capsule Summary:• The NPF COVID-19 TF produced 27 guidance statements to promote optimal management of psoriatic disease during the pandemic. • Shared decision making, adherence to evidence-based treatment, and the urgent use of novel COVID-19 vaccination are recommended. The guidance statements will be updated in accordance with the rapidly evolving science of COVID-19.

Cutaneous rosacea is a common inflammatory skin disorder that often presents with facial papulopustular lesions that are frequently bothersome to patients. Studies have shown oral sarecycline to be effective and safe for acne, with a low risk of side effects that are historically associated with other tetracycline-class drugs such as doxycycline and minocycline, in addition to offering a reduced risk of emergence of resistant bacteria due to its narrow-spectrum of antibiotic activity. Oral sarecycline is FDA-approved for the treatment of acne (2018).A pilot study to evaluate the efficacy and safety of oral sarecycline in papulopustular rosacea.A 12-week, prospective, parallel-group, investigator-blinded, controlled pilot study was completed evaluating once-daily sarecycline, using weight-based oral dosing as recommended for acne vs control (multivitamin tablet), for the treatment of moderate-to-severe papulopustular rosacea in adult subjects (n=102), aged ≥18 years. The primary efficacy endpoint was Investigator’s Global score (IGA; clear or almost clear) and percent reduction in inflammatory lesion count at week 12. Safety and tolerability assessments were performed as well.A total of 102 subjects were randomized; 97 completed the study. At week 12, IGA improvement was significantly greater for oral sarecycline when compared to the control (P0.0001). Furthermore, absolute and percent reductions in inflammatory lesion counts were significantly greater in the sarecycline group for all weeks (4, 8, and 12) when compared to the control (P0.001). Significant improvement in facial burning, erythema, and pruritus was reported in the sarecycline group, when compared to the control (P0.05). No serious AEs were reported.Sarecycline was effective, safe, and well-tolerated for treating papulopustular rosacea in adults with marked superiority in efficacy compared to subjects in the control group. With its narrow-spectrum activity, oral sarecycline may be a good option for the treatment of papulopustular rosacea. Additional studies are warranted to confirm the positive results of this pilot study.

Impetigo is a contagious bacterial infection that affects the superficial skin layers. Increasing worldwide antimicrobial resistance (AMR) to existing topical agents commonly prescribed to treat impetigo is central to treatment failure. The Worldwide Health Organization developed a global action plan on AMR, but omitted information about AMR stewardship programs for topical antibiotics.The review aims to provide information to clinicians and stakeholders regarding AMR and antimicrobial stewardship on topical antimicrobial drugs for impetigo treatment.The literature searches reviewed the status of AMR to current topical antibiotics in impetigo, current therapeutic behavior, and concordance with antimicrobial stewardship principles. Two international panels convened to discuss the output of the searches, and the results of the panel discussions were used in the development of the manuscript.The literature search included clinical trials, research studies, clinical guidelines, consensus papers, and reviews (if they provided original data), published between January 2008 and May 2019. The articles were selected based on clinical relevancy of impetigo management, clinical efficacy, and safety of the treatment and antimicrobial resistance. The searches resulted in one-hundred and ninety-eight articles. After applying the eligibility criteria, nineteen articles met inclusion criteria and were considered in the present review.While published antimicrobial stewardship guidelines have focused on systemic antibiotics, few studies have attempted to evaluate topical antibiotic prescribing practices for impetigo treatment. Many of the topical impetigo treatments currently in use have developed resistance. The appropriate use of topical ozenoxacin can help eradicate impetigo while minimizing AMR.J Drugs Dermatol. 20(4):366-372. doi:10.36849/JDD.5795.

Summary Background Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin‐13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms. Objectives To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate‐to‐severe AD who had an inadequate response to topical treatments. Methods In two 52‐week, randomized, double‐blind, placebo‐controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate‐to‐severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Primary endpoints were Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. The trials were registered with ClinicalTrials.gov: NCT03131648 and NCT03160885. Results At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 [difference 8·6%, 95% confidence interval (CI) 4·1–13·1; P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 (11·1%, 95% CI 5·8–16·4; P, What is already known about this topic? Atopic dermatitis (AD) is a chronic interleukin (IL)‐13‐mediated disease.There is a need for safe and effective long‐term treatment options for AD.Tralokinumab is a fully human monoclonal antibody that binds specifically to IL‐13 with high affinity, thereby preventing receptor interaction and subsequent downstream signalling.Tralokinumab combined with topical corticosteroids showed early and sustained efficacy and safety in a 12‐week, phase IIb trial in moderate‐to‐severe AD. What does this study add? These are the first pivotal phase III trials demonstrating that by specifically targeting IL‐13 alone, patients can achieve significant improvements in AD signs and symptoms and quality of life, and maintain these improvements over time without the requirement for topical corticosteroids.These trials provide evidence that tralokinumab offers a long‐term, well‐tolerated treatment option for patients with moderate‐to‐severe AD. Linked Comment: Morra and Drucker. Br J Dermatol 2021; 184:386–387. Plain language summary available online

OBJECTIVE: This study was conducted to assess compatibility of tretinoin 0.05% acne lotion with foundation makeup. DESIGN: This was a single-center, evaluator-blinded, randomized, controlled clinical trial. Participants were randomized to apply tretinoin 0.05% lotion to either the right or left side of the face before applying full-face foundation makeup. SETTING: Participants were enrolled at a single center in the United States. PARTICIPANTS: Female individuals aged 18 to 50 years who used facial foundation makeup ≥5 days per week were included. MEASUREMENTS: Investigator-assessed grading for foundation coverage and participant evaluations of makeup appearance were conducted at post-makeup application (Post-Makeup) and Hour 6 (6H) timepoints. Antera 3D® images were taken for skin texture roughness analysis and tolerability evaluations were performed at baseline, post-tretinoin application, Post-Makeup, and 6H timepoints. RESULTS: A total of 30 participants were enrolled and 29 completed the study. There were no significant differences between tretinoin treated and untreated sides for any outcomes of investigator-assessed grading of foundation (percentage coverage, blotchiness, overall coverage, skin tone evenness, visual smoothness). There was a small but statistically significant worsening in percent coverage at 6H versus Post-Makeup on the untreated side, but not the treated side. As rated by participants, even/full coverage and skin smoothness were significantly better on the tretinoin-lotion treated versus the untreated side. Three-dimensional imaging showed there were no significant differences in skin roughness between the treated and untreated sides. Participants reported overall satisfaction with the tretinoin lotion-treated side. CONCLUSION: Tretinoin 0.05% lotion did not interfere with facial makeup application or wearability and was well tolerated.

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Background In two phase 3 trials (NCT03168334, NCT03168321), participants with moderate-to-severe acne had significant symptom improvements after 12 weeks of treatment with tazarotene 0.045% lotion. Given the negative psychosocial effects of acne on patients, data from these studies were analyzed to evaluate quality of life in various subgroups. Methods Mean changes from baseline to week 12 in Acne-Specific Quality of Life (Acne-QoL) domain and item scores were analyzed in the pooled intent-to-treat (ITT) population and in participants who were categorized as follows: Evaluator's Global Severity Score (EGSS) score=3 (lmoderater) or score=4 (lseverer) at baseline; Acne-QoL total score g60 (better quality of life) or l60 (worse quality of life), based on the median score at baseline. Exploratory analyses based on sex and race were also performed. Results In the pooled ITT population (N=1614), Acne-QoL improvements were greater with tazarotene 0.045% lotion versus vehicle lotion, with significant differences in the acne symptoms domain, 3 acne symptom items, 2 self-perception items, 1 role-emotional item, and 1 role-social item (all Pl0.05). Acne-QoL improvements with tazarotene 0.045% lotion were comparable between the EGSS subgroups. However, participants who self-reported worse quality of life at baseline (Acne-QoL total score l60) had notably greater improvements than those with better quality of life. Female and Black participants had greater Acne-QoL improvements than male and White participants. Conclusions Participants treated with tazarotene 0.045% lotion had significant quality-of-life improvements. Clinician-rated symptom severity appeared to have a smaller effect on Acne-QoL outcomes than participantsr own assessments of quality of life. J Drugs Dermatol. 2020;19(11): doi:10.36849/JDD.2020.5457.

Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD).To evaluate 8-week efficacy and safety in 2 phase 3 studies of RUX cream in patients with AD.Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment score of 2/3, and 3%-20% affected body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream for 8 continuous weeks. The primary endpoint was Investigator's Global Assessment treatment success at week 8 (Investigator's Global Assessment score of 0/1 and ≥2-grade improvement from baseline).In the Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 and 2, 631 and 618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved Investigator's Global Assessment treatment success with 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) versus vehicle (15.1%/7.6%; P .0001) at week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P .05). Application site reactions were infrequent (1%) and lower with RUX versus vehicle; none were clinically significant.Longer-term safety data are not yet available.RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.

To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis.A 16-week, investigator-blinded study in patients with moderate psoriasis (Physicianrsquo;s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessmentsndash; Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL)ndash; and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16.28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score ofldquo;clearrdquo; orldquo;almost clearrdquo; (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated.In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.

In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation. Data from these studies were analyzed post hoc to investigate the effects of tretinoin 0.05% lotion on patient-reported quality of life, as assessed using the Acne-Specific Quality of Life Questionnaire (Acne-QoL). Mean changes from baseline to week 12 in Acne-QoL scores were analyzed in the pooled intent-to-treat population and a subgroup with treatment success (≥ 2-grade improvement on the Evaluator’s Global Severity Scale and rating of “clear” or “almost clear”). Pearson correlations were conducted in the pooled intent-to-treat population to assess the relationship between the Acne-QoL acne symptoms domain and each of the other three domains. In the pooled intent-to-treat population (n = 1640), greater mean improvements were found with tretinoin 0.05% lotion vs vehicle in all four domains: self-perception (mean change: 7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); acne symptoms (6.5 vs 5.6); all p

Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.

Background: Two identical phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT03168321 and NCT03168334) demonstrated the efficacy and safety of tazarotene 0.045% lotion in participants with moderate-to-severe acne. Data from these studies were pooled and analyzed post hoc to evaluate outcomes by sex. Methods: Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Outcomes comprised inflammatory/noninflammatory lesion counts, treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 [“clear”] or 1 [“almost clear”]), and treatment-emergent adverse events (TEAEs). Results: A total of 1,064 females and 550 males were included in this analysis. For both sexes, least-squares mean percent changes from baseline to week 12 in lesion counts were significantly greater with tazarotene 0.045% lotion versus vehicle (inflammatory: females, -60.1% vs -52.1%; males, -53.6% vs -39.8%; noninflammatory: females, -57.6% vs -44.9%; males, -52.9% vs -36.5%; P

The effects of androgens on human skin include growth and differentiation of sebaceous glands, terminal hair growth, epidermal barrier function, wound healing, and modification of the cutaneous microbiome. Androgens exert their activities via ligand formation with intracytoplasmic androgen receptors which can then translocate to the nucleus and interact with genetic androgen response elements to influence signaling cascades. Differences in tissue distribution and activities of enzymes that modify androgen synthesis and catabolism, variations related to gender and ethnicity/race, and genetic polymorphisms that affect androgen receptor functionality directly impact androgen physiology and the pathophysiology associated with a variety of disease states. This manuscript reviews the fundamentals of androgen physiology, androgen synthesis and catabolism in local skin tissue, androgen receptor activity, as well as the impact of genetic polymorphisms and gender. Emphasis is placed on the roles of androgenic activity in sebaceous gland development, sebum production, and the pathophysiology of acne vulgaris. J Drugs Dermatol. 2020;19(3 Suppl 1):s30-35.

Of the four primary pathogenic factors that drive acne vulgarismdash;androgen excess, increased sebum production, faulty keratinization, and overgrowth of C. acnesmdash;androgen excess has been the most elusive therapeutic target. Oral contraceptive pills (OCPs) have direct effect on circulating hormones, but their potential use is limited to a subset of women. As such, a sizable portion of the population affected by acne vulgaris cannot even consider treatment with OCPs. While these systemic agents are generally associated with a low risk profile and have a history of safe and effective use, they are not entirely risk-free. Indirect androgen modulation through the use of spironolactone has become increasingly popular.

Topical psoriasis treatment relies on a reactive rather than a long-term proactive approach to disease relapse.Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam.Phase III trial (NCT02899962) included a 4-week open-label lead-in phase (Cal/BD foam once daily) and a 52-week, randomized, double-blind, maintenance phase. A total of 545 patients achieved treatment success (physician's global assessment "clear"/"almost clear," ≥2-grade improvement from baseline) and were randomized to proactive management (Cal/BD foam; n = 272) or reactive management (vehicle foam; n = 273) twice-weekly, with rescue treatment of Cal/BD foam once daily for 4 weeks upon relapse. Primary endpoint was time to first relapse (physician's global assessment "mild" or higher).A total of 251 randomized patients (46.1%) completed the trial. Median time to first relapse was 56 days (proactive) and 30 days (reactive). Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P .001). Number of relapses per year of exposure was 3.1 (proactive) and 4.8 (reactive). Cal/BD foam was well tolerated.Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis.Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.

Psoriasis, a T-cell mediated chronic dermatosis, has a complex etiopathogenesis. There has been extensive research into the aberrant immune response, which leads to the formation of clinical lesions, and the need for developing better and safer drugs has been unrelenting. The past two decades of research has opened up new areas of the immune pathway that can be targeted in order to control the disease. Therefore, we have seen the emergence of biologics which either target T-cell receptors or inhibit Tumor Necrosis Factor-alpha (TNF-α) or inhibit interleukins (IL) like IL-12, IL-17, IL-17 receptor, and more recently IL-23. Drugs specifically targeting the p19 subunit of IL-23 have shown promising results in the management of chronic plaque psoriasis. This has given way to the development of a new class of biologics, that is, the IL-23p19 inhibitors that have a better safety profile as compared to its predecessors. In this review, we shall scrutinize the role of IL-23 and Th17 cell signaling in the evolution of the psoriatic lesions and summarize the clinical experience with IL-23p19 inhibitors especially mirikizumab in the treatment of chronic plaque psoriasis.

Background: Patients with moderate-to-severe psoriasis can have symptoms resulting in significant impact on patient-reported outcomes (PROs). The effect of etanercept (ETN) in moderate-to-severe psoriasis patients who previously received apremilast (APR) was studied, including impact on PRO endpoints. Methods: In this multicenter, open-label, single-arm, phase 4 estimation study, patients with moderate-to-severe psoriasis who did not have adequate response to APR in the opinion of the investigator received ETN 50mg subcutaneous (SC) twice weekly for 12 weeks, followed by ETN 50mg SC once weekly for an additional 12 weeks. Analysis was conducted for PROs directly and by the Psoriasis Area and Severity Index (PASI) achievement thresholds. Results: Of the 80 patients enrolled, the Psoriasis Symptom Inventory (PSI; total and individual items) had substantial improvement at weeks 12 and 24. Improvement in PSI total score (percent; mean [SD]) in patients who achieved PASI 50, -75, and -90 at week 12 was 57% (30), 67% (24), and 83% (18), respectively and at week 24 was 56% (40), 68% (29), and 80% (25). DLQI responders by PASI 50, -75, and 90 achievements were 69%, 68%, and 90%, respectively, at week 12 and 68%, 77%, and 82% at week 24. The percent of patients reported being "very satisfied" or "satisfied" with treatment at week 12 was 79%, 81%, and 100%, respectively, and at week 24 was 77%, 86%, and 88%. Conclusion: Patient-reported symptoms are important outcomes to consider in psoriasis management. ETN provided benefits in patients who did not have adequate response with APR, with improvements seen in both psoriasis symptoms and patient impact. Clinical Trial Number: NCT02749370 J Drugs Dermatol. 2020;19(4):378-383. doi:10.36849/JDD.2020.4910.

Background: Plaque psoriasis can occur in all body regions, with the trunk and extremities among the most commonly affected areas. A fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion demonstrated efficacy and safety in patients with moderate-to-severe localized plaque psoriasis. This analysis evaluated patients where a psoriatic target lesion was identified on the leg. Methods: In two phase 3, multicenter, double-blind studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once-daily for 8 weeks. This pooled, post hoc analysis included a subset of participants who had a leg target lesion (HP/TAZ, n=148; vehicle, n=71). Efficacy assessments included treatment success (≥2-grade improvement) in psoriasis signs (erythema, plaque elevation, scaling) on the leg target lesion, and overall treatment outcomes, including overall treatment success (≥2-grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), affected Body Surface Area (BSA), and IGAxBSA composite score. Results: Psoriasis signs were reduced by week 8, with more HP/TAZ treated participants achieving treatment success for erythema (41.6%), plaque elevation (58.5%), and scaling (59.5%) on the leg compared with vehicle (12.5%, 19.2%, and 21.0%, respectively; P

BACKGROUND: Necrobiosis lipoidica (NL) and sarcoidosis are granulomatous disorders with an unknown pathogenesis. They may coexist in the same patient, which suggests a possible overlap between these diseases among shared granulomatous inflammatory pathways. Case Presentation: This study presents the case of a non-diabetic 52-year-old woman who presented with red-yellowish border plaques on the face and upper extremities previously diagnosed as sarcoidosis. After 13 years of inappropriate treatment, histopathological findings consistent with the clinical and para-clinical examination suggested the diagnosis of NL. After treatment with an intralesional injection of steroids, significant improvement was observed, and no recurrent lesions were found. CONCLUSION: Necrobiosis lipoidica may mimic cutaneous sarcoidosis. Prompt recognition and treatment of NL can be helpful for managing the disease. J Drugs Dermatol. 2020;19(1):92-94. doi:10.36849/JDD.2020.4675

There was a time in the not so distant past that when we were asked about skin care, we would advise any patient to “use a moisturizer.” This meant going to the local drug store and purchasing one of just a few hand or body lotions then on the market. Many of these were heavily scented and featured ingredients that we now know could actually damage the skin barrier and paradoxically dry the skin.

Introduction Le deucravatinib (DEUC) est un nouvel inhibiteur oral selectif et allosterique de TYK2. Dans les essais de phase 3 POETYK PSO-1 ( NCT03624127 ) et PSO-2 ( NCT03611751 ) dans le psoriasis en plaques (PP) modere a severe, le DEUC a ete significativement plus efficace que le placebo et l’apremilast sur le PASI 75 et le sPGA 0/1. Cette analyse a evalue l’efficacite en fonction de sous-groupes predefinis selon les traitements anterieurs. Materiel et methodes Les patients (pts) atteints de PP modere a severe ont ete randomises 1:2:1 pour recevoir un placebo, DEUC 6 mg 1×/j ou apremilast 30 mg 2×/j. L’utilisation anterieure de traitement biologique ou systemique oral, a l’exception de l’apremilast, etait autorisee apres une periode de « wash out » appropriee avant le debut de l’etude. L’utilisation d’une phototherapie anterieure etait autorisee jusqu’a 4 semaines avant le debut de l’etude. Les co-criteres d’evaluation principale etaient le PASI 75 et le sPGA 0/1 a la semaine 16. Dans cette analyse, les reponses PASI 75 et sPGA 0/1 ont ete evaluees en fonction de l’utilisation anterieure de tout traitement systemique (biologique ou systemique oral), d’agents biologiques pour le psoriasis ou d’autres maladies inflammatoires (incluant les anticorps anti-IL-17, anti-IL-23 et anti-IL-12p40, les TNF inhibiteurs), et de la phototherapie (oui/non pour tous). Resultats Au total, 666 et 1020 pts ont ete respectivement randomises dans PSO-1 et PSO-2. Dans PSO-1, 62,8 % des pts avaient deja recu un traitement systemique anterieur, 38,9 % des pts (259/666) avaient deja recu un traitement biologique, 23,9 % (159/666) avaient deja recu un traitement oral systemique et aucun traitement biologique, et 35,9 % (239/666) une phototherapie. Dans PSO-2, 54,2 % des pts ont recu un traitement systemique anterieur, 32,1 % (327/1020) un traitement biologique anterieur, 22,2 % (226/1020) un traitement systemique oral anterieur et aucun traitement biologique, et 42,6 % (435/1020) une phototherapie. Dans l’ensemble des 2 essais, un nombre significativement plus eleve de pts recevant DEUC vs placebo et vs apremilast ont atteint un PASI 75 (PSO-1 : 58,7 % vs 12,7 % vs 35,1 %, p Discussion Dans les etudes POETYK PSO-1 et PSO-2, le DEUC a montre des taux de reponse PASI 75 et sPGA 0/1 superieurs a ceux du placebo et de l’apremilast, independamment du traitement anterieur recu (phototherapie, traitement systemique ou biologique).