Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials.

BACKGROUND: Tapinarof cream 1% once daily (QD), a topical aryl hydrocarbon receptor agonist, downregulates pro-inflammatory Th2 cytokines, upregulates skin-barrier components, and reduces oxidative stress. OBJECTIVE: To assess tapinarof efficacy and safety in adults and children down to 2 years of age with atopic dermatitis (AD). METHODS: Eight hundred and thirteen patients were randomized to tapinarof or vehicle QD in two 8-week phase 3 trials. RESULTS: The primary efficacy endpoint, Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and ≥2-grade improvement from baseline at Week 8, was met with statistical significance in both trials: 45.4% versus 13.9% and 46.4% versus 18.0% (tapinarof vs vehicle; both P < .0001). Significantly superior Eczema Area and Severity Index 75 (EASI75) responses were also observed with tapinarof versus vehicle at Week 8: 55.8% versus 22.9% and 59.1% versus 21.2% (both P < .0001). Rapid improvements in patient-reported pruritus were also significant with tapinarof versus vehicle. Common adverse events (≥5%) of folliculitis, headache, and nasopharyngitis were mostly mild or moderate, with lower discontinuations due to adverse events in the tapinarof groups than with vehicle. LIMITATIONS: Long-term efficacy was not assessed. CONCLUSION: Tapinarof demonstrated highly significant efficacy and favorable safety and tolerability in a diverse population of patients with AD down to 2 years of age.

Racial and Ethnic Variations in Skin Barrier Properties and Cultural Practices in Skin of Color Newborns, Infants, and Children.

BACKGROUND: The skin of newborns and infants of all races/ethnicity is more susceptible to skin barrier disruption than adult skin. This consensus paper offers insights into potential skincare implications for using gentle cleansers and moisturizers for skin of color (SOC) newborns, infants, and children. METHODS: Six pediatric dermatologists and dermatologists used a Delphi communication technique to adopt 5 statements for SOC newborns, infants, and children on skin barrier integrity and the importance of skin care to promote a healthy skin barrier.  Results: Regardless of ethnicity, newborn and infant skin is still developing and more susceptible to infections and chemical and thermal damage. A growing body of evidence supports skincare starting early in life, recognizing that the ongoing daily use of gentle cleansers and moisturizers containing barrier lipids, such as ceramides, promotes a healthy skin barrier. Understanding cultural differences in everyday skincare practices for SOC newborns, infants, and children is critical for developing an evidence base to substantiate skincare practices.  Conclusions: Closing knowledge gaps in the clinical presentation, cultural differences, and approach to treating skin conditions using skincare for SOC newborns, infants, and children may improve patient outcomes.   Schachner  LA, Andriessen A, Benjamin  L, et al. Racial/ethnic variations in skin barrier properties and cultural practices in skin of color newborns, infants and children. J Drugs Dermatol. 2023;22(7):657-663. doi:10.36849/JDD.7305.

Diagnosis and Management of Pediatric Psoriasis: An Overview for Pediatricians.

Pediatric psoriasis (PsO) and its associated comorbidities carry physical and psychosocial burdens in children and adolescents, which can negatively impact quality of life. However, features distinguishing pediatric PsO from eczema and other common inflammatory skin diseases may not be obvious to primary care providers, which may contribute to underrecognition and misdiagnosis. Accurate diagnosis of pediatric PsO is critical for managing the physical and psychological burdens associated with this disease. This review aims to support pediatricians with enough information to confidently diagnose pediatric PsO, assess associated physical and mental health comorbidities, and recommend first-line treatment options for children with mild to moderate PsO. To accomplish this, we provide information that distinguishes the appearance and symptoms of pediatric PsO from other common pediatric skin conditions. In addition, comorbidities and some of the mental health challenges associated with pediatric PsO are reviewed to help pediatricians provide appropriate care for patients in their clinical practice. Hebert AA, Browning J, Kwong PC, et al. Diagnosis and management of pediatric psoriasis: an overview for pediatricians. J Drugs Dermatol. 2023;22(8):742-752. doi:10.36849/JDD.7531.

Consensus Statements on the Use of Corticosteroid-Containing Topical Medications in Psoriasis.

This article aims to provide consensus statements on the use of corticosteroid-containing topical medications for the management of psoriasis. This Psoriasis Expert Group (PEG) includes dermatologist voting members with expertise in psoriasis who convened and evaluated the use of topical medications and previously published guidelines. A modified Delphi process was conducted to reach consensus results. Two rounds of voting were conducted for each topic and panel consensus was determined.  Nine statements were developed regarding topical medication efficacy, patient quality of life, frequency of application, medication "feel", and safety and tolerability. Dermatologist experts voted on the statements separately. Patients were not polled. All items received agreement: 15 with high consensus and 1 with moderate consensus.  For the treatment of psoriasis, the PEG agreed that patients and physicians prefer topical medications that are effective, provide long-lasting results, have a quick onset of action, and "feel good on the skin" with few adverse effects. The developed consensus statements provide guidance on the topical treatment of psoriasis, including combination therapies, such as a vitamin D and topical corticosteroid analog. These recommendations will be continuously reviewed and updated as more evidence continues to emerge.  April W. Armstrong AW, Reddy R, Khan S, et al. Consensus statements on the use of corticosteroid-containing topical medications in psoriasis. J Drugs Dermatol. 2023;22(8):736-741. doi:10.36849/JDD.7453.

Advances in Topical Management of Adolescent Facial and Truncal Acne: A Phase 3 Pooled Analysis of Safety and Efficacy of Trifarotene 0.005% Cream.

PURPOSE: Acne vulgaris is very common among adolescents and young adults. It is important for clinicians who provide care to these patients to have a plan of action for assessing and managing acne in daily practice. METHODS: Post-hoc analysis of two large-scale phase 3 pivotal trials of trifarotene 0.005% cream, focusing on efficacy, safety, and tolerability in the subgroup of subjects aged 12 to 17, inclusive. RESULTS: Trifarotene was effective and well tolerated on both the face and trunk in patients ages 12-17 with moderate acne. There was a low and acceptable rate of adverse events and tolerability was favorable. CONCLUSIONS: Trifarotene monotherapy was associated with good clinical efficacy, safety, and tolerability. Once-daily application offers convenience for patients, and the low concentration of trifarotene makes it well-suited to use on large skin areas such as the trunk. J Drugs Dermatol. 2022;21(6):582-586. doi:10.36849/JDD.6778.

Treatment of Impetigo and Antimicrobial Resistance.

BACKGROUND: 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. OBJECTIVES: The review aims to provide information to clinicians and stakeholders regarding AMR and antimicrobial stewardship on topical antimicrobial drugs for impetigo treatment. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Do Antimicrobial Resistance Patterns Matter? An Algorithm for the Treatment of Patients With Impetigo.

BACKGROUND: Impetigo, a highly contagious bacterial skin infection commonly occurring in young children, but adults may also be affected. The superficial skin infection is mainly caused by Staphylococcus aureus (S. aureus) and less frequently by Streptococcus pyogenes (S. pyogenes). Antimicrobial resistance has become a worldwide concern and needs to be addressed when selecting treatment for impetigo patients. An evidence-based impetigo treatment algorithm was developed to address the treatment of impetigo for pediatric and adult populations. METHODS: An international panel of pediatric dermatologists, dermatologists, pediatricians, and pediatric infectious disease specialists employed a modified Delphi technique to develop the impetigo treatment algorithm. Treatment recommendations were evidence-based, taking into account antimicrobial stewardship and the increasing resistance to oral and topical antibiotics. RESULTS: The algorithm includes education and prevention of impetigo, diagnosis and classification, treatment measures, and follow-up and distinguishes between localized and widespread or epidemic outbreaks of impetigo. The panel adopted the definition of localized impetigo of fewer than ten lesions and smaller than 36 cm2 area affected in patients of two months and up with no compromised immune status. Resistance to oral and topical antibiotics prescribed for the treatment of impetigo such as mupirocin, retapamulin, fusidic acid, have been widely reported. CONCLUSIONS: When prescribing antibiotics, it is essential to know the local trends in antibiotic resistance. Ozenoxacin cream 1% is highly effective against S. pyogenes and S. aureus, including methycyllin-susceptible and resistant strains (MRSA), and may be a suitable option for localized impetigo.J Drugs Dermatol. 2021;20(2):134-142. doi:10.36849/JDD.5475 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.

Consensus on Neonatal Through Preadolescent Acne.

BACKGROUND: Acne vulgaris is the most common dermatological disorder. Pediatric acne may be a manifestation of the underlying pathology and can occur in the first weeks, months, or years of life. Acne in childhood can be categorized by age and pubertal status. OBJECTIVE: An expert panel of pediatric dermatologists and dermatologists developed a consensus paper on neonatal through preadolescent acne, providing information on differential diagnosis, prevention, treatment, and maintenance of the condition. METHODS: A systematic literature review explored present clinical guidelines, treatment options, and therapeutic approaches addressing neonatal through preadolescent acne. The information from the literature searches was used together with the panel’s expert opinion and experience to adopt consensus statements following established standards. RESULTS: The panel members reached unanimous consensus on seven statements addressing the various age categories of pediatric acne: neonatal acne: birth to ≤ 8 weeks; infantile acne: 8 weeks to ≤1 year; mid-childhood acne: 1 year to <7 years; preadolescent acne: ≥7 to 12 years; adolescent acne: ≥12 to 19 years or after menarche for girls. Health care providers treating children need to pay more attention to pediatric acne and should monitor the risk of endocrine-associated abnormalities, especially in mild-childhood acne. When prescribing acne treatment, newer medications approved for use in children older than nine years of age may offer a suitable option. CONCLUSION: The differential diagnosis of pediatric acne, as well as its treatment and maintenance, requires much more attention and consideration from health care providers treating children. J Drugs Dermatol. 2020;19(6):592-600. doi:10.36849/JDD.2020.5065.

Treatment of Impetigo in the Pediatric Population: Consensus and Future Directions.

BACKGROUND: Impetigo is a common contagious superficial bacterial skin infection. Treatment of localized lesions can be achieved through topical antibiotics. Oral antibiotics are reserved for extensive disease. Increasing antimicrobial resistance to existing therapies have raised concerns. Antimicrobial stewardship, achieved through the responsible use of antibiotics, is an important measure to re-duce bacterial resistance. This review highlights treatment options for impetigo and shares consensus statements to help guide the management of impetigo in the pediatric population. OBJECTIVE: An expert panel of dermatologists and pediatricians convened in February 2019 to establish evidence-based consensus on the management of impetigo in the pediatric patient population. METHODS: The consensus was created in accordance with the Appraisal of Guidelines, Research and Evaluation (AGREE) II instrument. Prior to the consensus meeting, a systematic literature review was conducted, with the selected literature deemed clinically relevant to the consensus statements. Statements were further refined and assessed systematically following established standards. The consensus process consisted of a modified Delphi approach. The consensus was established through a minimal 75% “agree” rate. RESULTS: Thirteen consensus statements were developed addressing clinical challenges, existing treatment options and their limita-tions, and new therapeutic alternatives. CONCLUSION: Bacterial resistance to antimicrobials commonly used in treating impetigo has been reported. Antimicrobial stewardship is critical to optimize patient outcomes and to prevent the development of resistance. Healthcare providers should be aware of local resistance patterns in impetigo to help guide therapy. The use of newer safe and effective topical antibiotic alternatives as a first-line treatment should be an important step in antimicrobial stewardship.J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.4679.

Impact of Topical Vehicles and Cutaneous Delivery Technologies on Patient Adherence and Treatment Outcomes in Acne and Rosacea.

Objective: Topical therapies remain the mainstay in treating patients with acne and rosacea. However, emerging real-world evidence demonstrates that desired treatment outcomes might not be achieved if patient satisfaction and adherence are low. Poor tolerability of active drug(s) and vehicle components and/or the drug delivery system could negatively influence adherence. Additionally, adherence might be lower with complex treatment regimens involving the application of multiple topical formulations. Optimizing vehicle tolerability and simplifying regimens that use fixed-dose combinations may improve treatment outcomes, better patient satisfaction, and reduce overall treatment costs. This qualitative review discusses several innovative drug delivery technologies and formulations aimed at improving patient satisfaction and adherence. Methods: The authors conducted a search of current and emerging topical drug delivery technologies used in clinical studies, reviewed primary literature on the chemical characteristics of topical dosage forms, and compared the impacts on treatment outcomes for acne and rosacea. Results: This article provides insight into innovative vehicles and drug delivery systems that have emerged allowing for fixed-dose combinations of incompatible active drugs and improving the tolerability of historically irritative active ingredients. Limitations: Further research is needed to fully highlight the impact of patient satisfaction and modern topical formulations on adherence and treatment outcomes. Conclusion: Drug microencapsulation is a delivery technology that has enabled development of a topical fixed-dose combination of benzoyl peroxide and tretinoin preventing the oxidation of tretinoin by benzoyl peroxide and improving the tolerability of the active ingredients.

Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials.

BACKGROUND: Plaque psoriasis affects ~ 1% of the pediatric population, negatively impacting quality of life. The efficacy and safety of secukinumab in pediatric patients with moderate to severe or severe chronic plaque psoriasis have been established in two pivotal phase 3 trials (open-label, NCT03668613; double-blind, NCT02471144). OBJECTIVES: The aims were to report the pooled safety of secukinumab up to 52 weeks from two studies in subgroups of pediatric patients stratified by age and bodyweight, and to present, alongside the pediatric data, the pooled safety data from four pivotal adult secukinumab trials. METHODS: The safety of secukinumab was evaluated in subgroups of pediatric patients defined by age (6 to < 12 and 12 to < 18 years) and bodyweight (< 25 kg, 25 to < 50 kg, and ≥ 50 kg) in the pooled population. Patients received secukinumab low dose (LD; 75/75/150 mg), secukinumab high dose (HD; 75/150/300 mg), placebo, or etanercept (0.8 mg/kg). For safety analyses, data were pooled from the pediatric studies NCT03668613 and NCT02471144, and presented alongside the pooled data from four adult pivotal studies (NCT01365455, NCT01636687, NCT01358578, NCT01555125). RESULTS: A total of 198 pediatric patients (overall exposure: 184.6 patient-years [PY]) and 1989 adult patients (1749.5 PY) receiving secukinumab up to week 52 were included in this analysis. At week 52, the incidence of adverse events (AEs) was lower in the lower age and bodyweight subgroups. The AEs reported within these subgroups were consistent with the overall AEs reported in this analysis. Overall, exposure-adjusted incidence rates for treatment-emergent AEs were lower in the secukinumab-treated pediatric pool (198.8/100 PY) compared with the etanercept (266.3/100 PY) and adult pools (256.1/100 PY). Up to 52 weeks, the incidence rates of the AEs in the secukinumab-treated patients in the 6 to < 12 years subgroup and 12 to < 18 years subgroup were 167.7/100 PY and 214.7/100 PY, respectively. Similarly, incidence rates of the AEs in the secukinumab-treated patients in the < 25 kg, 25 kg to < 50 kg, and ≥ 50 kg subgroups were 177.3/100 PY, 192.5/100 PY, and 206.8/100 PY, respectively. Nasopharyngitis was the most frequently reported AE in secukinumab-treated pediatric patients across age (< 12 years: 11.8/100 PY; ≥ 12 years: 42.4/100 PY) and bodyweight (< 25 kg: 22.8/100 PY; 25 kg to < 50 kg: 19.0/100 PY; ≥ 50 kg: 43.0/100 PY). Of the 198 secukinumab-treated pediatric patients, one reported nail Candida, one reported skin Candida, and two reported vulvovaginal Candida. Transient and mostly mild events of neutropenia were observed with secukinumab, none leading to study treatment discontinuation. No incidence of treatment-emergent anti-drug antibodies was reported in pediatric patients treated with secukinumab. CONCLUSIONS: Secukinumab was well tolerated in pediatric patients with moderate to severe and severe plaque psoriasis across age and bodyweight subgroups. The overall safety profile of secukinumab in pediatric patients was consistent with that of adult patients. GOV IDENTIFIER: NCT03668613 (Novartis Study Code CAIN457A2311, referred to as A2311), actual study start date: August 29, 2018; actual primary completion date: September 19, 2019; estimated study completion date: September 14, 2023. NCT02471144 (Novartis Study Code CAIN457A2310, referred to as A2310), study start date: September 29, 2015; primary completion date: December 13, 2018; estimated study completion date: March 31, 2023.

COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts.

INTRODUCTION: Verrucae vulgaris, or common warts, is a common skin condition for which there is no US Food and Drug Administration-approved treatment. Compounded cantharidin has been used to treat warts for years but lacks a controlled formulation, consistent application schedule and methods, and robust safety and efficacy studies. VP-102 is a proprietary drug-device combination product containing a topical formulation of 0.7% (w/v) cantharidin in a single-use delivery device. This objective of the phase 2 study was to evaluate the efficacy, safety, tolerability, and optimal regimen of VP-102 in the treatment of common warts. METHODS: In this open-label trial, participants aged ≥ 2 years with one to six common warts were administered VP-102 topically to treatable common warts once every 14 days (Cohort 1) or once every 21 days in conjunction with paring (Cohort 2), for up to four treatments. Participants were evaluated through to day 84 (Cohort 1) or day 147 (Cohort 2). The primary endpoint was the percentage of participants with complete clearance of all treatable common warts (baseline and new) at day 84. Secondary endpoints included percentage of participants achieving complete clearance of all treatable common warts at other visits. Safety assessments included treatment-emergent adverse events (TEAEs), including local skin reactions (LSRs). RESULTS: A total of 21 and 35 participants were enrolled in Cohort 1 and Cohort 2, respectively. Complete clearance at day 84 was seen in 19.0% of participants in Cohort 1 and 51.4% of those in Cohort 2. The most common TEAEs were expected LSRs and included application site vesicles, pain, pruritus, erythema, and scab. Most LSRs were mild or moderate in severity. CONCLUSION: VP-102 showed efficacy in complete clearance of common warts from baseline to day 84, as well as at follow-up visits. Due to the higher percentage of patients exhibiting complete clearance in Cohort 2, the treatment regimen of Cohort 2 will be pursued in future studies. TEAEs were expected due to the pharmacodynamic action of cantharidin, a vesicant. Clinical Trials ID: NCT03487549.

Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials.

TRIAL REGISTRATION: >ClinicalTrials.gov identifier nos. NCT03377790 (for CAMP-1) and NCT03377803 (for CAMP-2). BACKGROUND: VP-102 is drug-device combination product containing cantharidin (0.7% w/v) and has undergone Phase III clinical trials for the treatment of molluscum contagiosum (molluscum). Efficacy and safety may differ by body region due to variable skin anatomy. OBJECTIVE: We investigated the pooled safety and efficacy of VP-102 by affected body region. METHODS: Individuals at least two years of age with molluscum were randomized to topical VP-102 or vehicle once every 21 days until clear (maximum of four applications). Participants were assigned to body region groups where lesions were present at baseline. Body region lesion counts were recorded at each visit. Efficacy was measured by the percentage of participants with complete clearance of lesions by region. Pre-specified adverse events (AEs) were analyzed for those treated in the region on that visit. RESULTS: Participants had a mean of two regions affected at baseline. Complete clearance was significantly higher in the VP-102-treated group than with vehicle application in all regions at the last visit (P<0.01 for each region). The incidence of pre-specified AEs was consistent across regions. However, these analyses were post hoc, and individual lesions were not tracked for efficacy. CONCLUSION: VP-102 treatment shows consistent safety and efficacy across molluscum body regions.

Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum.

BACKGROUND: Compounded cantharidin has been used for decades to treat molluscum contagiosum but lacks rigorous clinical evidence to support its safety and efficacy. VP-102 is a shelf-stable drug-device combination product that contains topical cantharidin (0.7% weight/volume [w/v]) and is being evaluated for the treatment of molluscum. OBJECTIVES: Our objective was to present pooled safety and efficacy analyses of VP-102 in the treatment of molluscum compared with vehicle. METHODS: Participants aged ≥ 2 years were randomized 3:2 to topical administration of VP-102 or vehicle in two randomized, double-blind, vehicle-controlled phase III trials. Study drug was applied to all baseline and new lesions once every 21 days until clear or for a maximum of four applications. Assessors blinded to treatment counted all lesions at each study visit. All adverse events (AEs) were documented. Data were pooled for analyses. RESULTS: In total, 310 participants received VP-102 and 218 received vehicle. Mean age was 7.5 years (range 2-60) for VP-102 and 6.8 (2-54) for vehicle. Complete clearance of all molluscum lesions at day 84 occurred in 50% of VP-102 participants and 15.6% of vehicle recipients (p < 0.0001). Mean molluscum lesion counts decreased 76% for VP-102 and 0.3% for vehicle at day 84 (p < 0.0001). The most common AEs in the VP-102 group were application site blistering, pruritus, pain, and erythema, which were generally mild or moderate in severity. CONCLUSIONS: Pooled analyses showed a significantly higher percentage of participants with complete molluscum lesion clearance and larger reductions in lesion counts with VP-102 than with vehicle. AEs were anticipated because of the pharmacodynamic properties of cantharidin. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT03377790 (first posted 19 December 2017) and NCT03377803 (first posted 19 December 2017). Video abstract: Pooled Results of Two Randomized Phase III Trials Evaluating VP 102, a Drug Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum (MP4 131293 KB).

Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials.

Importance: Molluscum contagiosum (MC) is a common viral skin infection that primarily affects children. Cantharidin, a topical vesicant, has a long history of use for MC in compounded formulations, but the safety and efficacy of doses, regimens, and application methods have not been demonstrated in large-scale trials. Objective: To determine the safety and efficacy of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), compared with vehicle in individuals with MC. Design, Setting, and Participants: Two phase 3, randomized, double-blind, vehicle-controlled trials of identical design (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) were conducted in 31 centers across the US. A total of 528 individuals aged 2 years or older with MC participated. CAMP-1 was conducted from March 21 to November 26, 2018, and CAMP-2 was conducted from February 14 to September 26, 2018. Interventions: Participants were randomized (3:2) to topical application of VP-102 or vehicle to all treatable lesions every 21 days until complete lesion clearance or up to 4 treatments. Main Outcomes and Measures: The primary efficacy outcome was the proportion of VP-102-treated participants achieving complete clearance of all MC lesions (baseline and new) compared with those who received the vehicle at the end-of-study visit on day 84. Intent-to-treat analysis was conducted for the efficacy population. Secondary efficacy outcomes included the proportion of participants achieving complete clearance of lesions at days 21, 42, and 63. Safety outcomes included assessment of adverse events, including expected local skin reactions. Results: Of the 528 participants enrolled, 527 received treatment (CAMP-1, n = 265; CAMP-2, n = 262). A total of 267 of 527 participants (50.7%) were male; mean (SD) ages for CAMP-1 and CAMP-2 were 7.5 (5.3) years and 7.4 (8.0) years for the VP-102 groups and 6.3 (4.7) years and 7.3 (6.7) years for the vehicle groups. Treatment with VP-102 demonstrated superior efficacy to vehicle in the percentage of participants with complete clearance of MC lesions at the end of the study visit for CAMP-1 (VP-102: 46.3% vs vehicle: 17.9%; P < .001) and CAMP-2 (VP-102: 54.0% vs vehicle: 13.4%; P < .001). Adverse events were observed in 99% (CAMP-1) and 95% (CAMP-2) of VP-102-treated participants and 73% (CAMP-1) and 66% (CAMP-2) of vehicle-treated participants. The most common adverse events included application site vesicles, pain, pruritus, erythema, and scab. Most adverse events were mild or moderate in severity. Conclusions and Relevance: In the 2 phase 3 trials reported herein, VP-102 was statistically significantly superior to vehicle in achieving complete clearance of MC lesions at the end of the study visit in both trials, with adverse events that were generally mild to moderate and confined to application sites. These findings show that VP-102 is potentially an effective and safe treatment for MC, a common skin condition with no US Food and Drug Administration-approved treatments. Trial Registrations: ClinicalTrials.gov Identifiers: NCT03377790 and NCT03377803.

Intrascrotal sarcoidosis in a pediatric patient.

Sarcoidosis is a granulomatous disease with diverse skin manifestations and systemic involvement. We describe an adolescent boy who presented with unilateral scrotal swelling, constitutional symptoms, and a rash. Further workup demonstrated lymphadenopathy and pulmonary opacities. Granulomas caused by sarcoidosis were identified in biopsy specimens of the epididymis and skin lesions. No acid-fast organisms were found in biopsy specimens, and the patient had negative findings on placement of purified protein derivative (tuberculin). The concentration of angiotensin-converting enzyme was not elevated. We discuss pediatric sarcoidosis and, more specifically, intrascrotal sarcoidosis.

Topical tacrolimus in the treatment of inverse psoriasis in children.

Inverse psoriasis is a chronic disease frequently treated with topical corticosteroids. This retrospective case study evaluated the efficacy of tacrolimus 0.1% ointment to treat inverse psoriasis in children. Twelve of 13 patients had complete clearance of their psoriatic lesions within 2 weeks after initiating treatment with topical tacrolimus 0.1%.

Anterior encephalocele with subcutaneous right facial nodule.

Encephaloceles consist of heterotopic brain tissue that remains connected to the central nervous system. As such, these lesions can occur anywhere along the midline of the head, neck, and back. The clinical findings associated with an encephalocele are often cutaneous, prompting consultation with a dermatologist. Although abnormalities of the skin overlying the spinal cord are readily recognized by our specialty as markers for dysraphism, head and neck lesions may present a diagnostic challenge. We describe a case of an anterior encephalocele to increase awareness of this disorder and to emphasize the clinical findings that will assist with diagnosis. Our case is of particular interest because of the parasagittal location of the facial nodules and minimal actual midline involvement.

Treatment of Nevus comedonicus with topical tazarotene and calcipotriene.

Nevus comedonicus is a rare developmental defect of the pilosebaceous unit. It is also thought to be a variant of epidermal nevus. Previously reported treatments include surgical excision, CO2 laser, dermabrasion, extraction, topical retinoic acid, and numerous topical keratolytics. We present a case of a 7-year-old boy with bilateral nevus comedonicus who experienced cosmetic improvement with topical tazarotene and calcipotriene cream. This combination represents a novel therapeutic approach to the treatment of this cutaneous abnormality.