Atopic dermatitis (AD) has the highest incidence in 3-6-month-olds. Common topical prescription treatments (eg, corticosteroids, calcineurin inhibitors, and a phosphodiesterase 4 inhibitor [PDE4i; crisaborole]) have limited efficacy, adverse event (AE) concerns, and/or use restrictions. Roflumilast (ROF) cream is a highly potent PDE4i formulated without potentially irritating ingredients. Efficacy and safety of ROF cream 0.15% and 0.05% for the treatment of mild-to-moderate AD in ≥6-year-olds and 2-5-year-olds, respectively, have been demonstrated in phase 3 clinical trials. The phase 2, open-label, INTEGUMENT-INFANT/ NCT06998056 study is evaluating ROF cream 0.05% in infants aged 3 months to <2 years with AD (mild/moderate [2/3] Validated Investigator Global Assessment for AD [vIGA-AD]; ≥ 3% body surface area affected). Caregivers will apply ROF once daily for 4 weeks. Safety assessments include treatment-emergent adverse events and application-site tolerability. Efficacy assessments include vIGA-AD, Scalp-IGA, Eczema Area and Severity Index, Body Surface Area-Scalp and -Total, Worst Scratch/Itch-Numeric Rating Scale, Dynamic Pruritus Scale, and quality-of-life and family impact measures. Approximately 100 patients will be enrolled in the United States, Canada, and the Dominican Republic begining in June 2025. Outcomes from INTEGUMENT-INFANT will provide important data on the potential use of ROF cream 0.05% in infants aged 3 months to <2 years with mild to-moderate AD.

ABSTRACT Background/Objectives Efficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel‐group, double‐blind trial (INTEGUMENT‐PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2–5 years with AD. Methods Patients aged 2–5 years with mild‐to‐moderate AD were treated with once‐daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA‐AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2‐grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI‐75) and Worst Itch‐Numeric Rating Score (WI‐NRS) Success (≥ 4‐point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed. Results Among 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week‐4 vIGA‐AD Success (25.4% vs. 10.7%; p < 0.0001), EASI‐75 (39.4% vs. 20.6%; p < 0.0001), and WI‐NRS Success (35.3% vs. 18.0%; nominal p = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal p = 0.0014). Treatment‐emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group. Conclusions In this Phase 3 trial, once‐daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2–5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle. Trial Registration: ClinicalTrials.gov : NCT04845620

Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1

Background: Alopecia areata (AA) is an autoimmune disease characterized by hair loss that can negatively impact quality of life. AA has a significant pediatric prevalence; however, no systemic treatments are approved for AA in patients aged < 12 years. Ritlecitinib, a JAK3/TEC family kinase inhibitor, is approved to treat adults and adolescents with severe AA aged >= 12 years. This study evaluated ritlecitinib pharmacokinetic (PK) parameters and safety in pediatric patients with AA aged 6 to < 12 years. Methods: In this single-group, uncontrolled, open-label study, participants received ritlecitinib 20 mg once daily for 7 days. PK parameters of ritlecitinib on Day 7 were measured and summarized descriptively. Safety outcomes, including incidence of adverse events (AEs), were evaluated. Results: Fifteen participants were enrolled and 14 (93.3%) completed the study. The median time to maximum concentration (T-max) for plasma concentrations of ritlecitinib on Day 7 was similar to 0.5 h. The mean half-life of ritlecitinib was similar to 1.19 h. Geometric means (% coefficient of variation) for area under the curve from 0 to 24 h (AUC(24)) and maximum concentration (C-max) were 437.5 ng center dot h/mL (30%) and 208.7 ng/mL (38%), respectively. Four AEs were experienced by 3 participants, with 1 AE of urticaria resulting in permanent discontinuation. No severe AEs, serious AEs, or clinically meaningful laboratory abnormalities were reported. Conclusions: Ritlecitinib PK parameters in pediatric patients were successfully characterized in the present study. Ritlecitinib 20 mg once daily was generally well tolerated in pediatric patients with AA.

Background: Travis Park is a student-run free clinic in San Antonio that treats predominantly under-insured patients. COVID-19 exacerbated pre-existing healthcare barriers, including financial instability and impairment in public transport. (1) With 73.5% of Travis Park patients uninsured, analyzing demographics could provide insight into COVID-19 impacts on free clinic patients.

Background: Acne-induced post-inflammatory hyperpigmentation (PIH) is a common, long-lasting sequela of acne with a significant psychosocial impact. To assess its impact on sufferers, interviews were conducted in a phase IV study of trifarotene treatment of acne and PIH.

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.

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in adults and children down to 2 years of age with moderate to severe atopic dermatitis (AD) in the pivotal phase 3 ADORING 1 and 2 trials. Here, we present patient-reported outcomes (PROs). 407 and 406 patients were randomized 2:1 to tapinarof or vehicle QD for 8 weeks. PROs for health-related quality of life (HR-QoL) were assessed using Dermatology Life Quality Index (DLQI; age ≥16 years), Children's Dermatology Life Quality Index (CDLQI; 4-15 years), Infants' Dermatitis Quality of Life Index (IDQOL; 2-3 years), and Patient Oriented Eczema Measure (POEM). Means and mean changes from baseline at Week 8 are reported. Baseline DLQI, CDLQI, and IDQOL scores (ranges) were similar, 8.6-10.1, 8.6-9.7, and 10.0-11.6, respectively, across treatment groups and trials. Baseline POEM scores (range) were 16.4-17.4 (ages ≥12 and <12 years). Tapinarof improved HR-QoL versus vehicle across all endpoints: DLQI, –6.2 vs –3.5 (P=0.0031) and –5.5 vs –3.5 (P=0.0028); CDLQI, –5.2 vs –3.8 (P=0.0043) and –6.8 vs –4.1 (P<0.0001); IDQOL, –7.3 vs –2.6 (P<0.0001) and –6.9 vs –5.4 (P=0.4364), in ADORING 1 and 2. CDLQI sleep subdomain scores significantly improved with tapinarof versus vehicle. AD symptoms (POEM) improved with tapinarof versus vehicle: ≥12 years, –9.4 vs –5.3 and –10.6 vs –3.6 (both P<0.0001); <12 years, –11.4 vs –5.7 (P<0.0001) and –10.8 vs –7.3 (P=0.0005).

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

Pityriasis rosea (PR) is a common rash seen in children and adults. The underlying cause of PR is unknown but a viral etiology has long been suspected due to clustering of PR in the spring and fall. Human herpesvirus (HHV)-6 and HHV-7 have long been suspected as causative agents of PR but definitive evidence is lacking. One recent study showed the presence of HHV-8 in lesional skin of 7 out of 34 patients with PR. There are also many drugs that can cause a PR-like reaction.

Abstract Introduction Tapinarof cream 1% once daily (QD) demonstrated efficacy versus vehicle and was well tolerated in adults and adolescents with moderate to severe atopic dermatitis (AD) in a previously reported phase 2 trial. Objective Here, we report pivotal phase 3 efficacy and safety results for tapinarof cream 1% QD in the treatment of adults and children down to 2 years of age with AD. Materials and Methods ADORING 1 and 2 were two identical phase 3, randomized, double-blind, vehicle-controlled trials. Eligibility criteria included a Validated Investigator Global Assessment for Atopic DermatitisTM (vIGA-ADTM) score of ≥3, Eczema Area and Severity Index (EASI) score of ≥6, and body surface area (BSA) involvement of 5–35%. Patients were randomized 2:1 to receive tapinarof cream 1% or vehicle cream QD for 8 weeks. The primary efficacy endpoint was vIGA-ADTM response, defined as a score of clear (0) or almost clear (1) and ≥2-grade improvement from baseline at Week 8. Secondary efficacy endpoints included ≥75% improvement in EASI score (EASI75) and proportion of patients (aged ≥12 years) with a baseline Peak Pruritus-Numerical Rating Scale (PP-NRS) score of ≥4 who achieved a ≥4-point reduction at Week 8. Adverse events (AEs) included rates of AEs of special interest (AESIs): contact dermatitis, follicular event, and headache. Results 407 and 406 patients aged 2–81 years were randomized in ADORING 1 and 2, respectively. At baseline, 84.0–89.9% of patients had a vIGA-ADTM score of 3 (moderate), mean EASI score of 12.5–13.3, and mean BSA affected of 16.7–16.9% across trials. At Week 8, both the primary and all secondary efficacy endpoints were met with statistical significance in the tapinarof groups versus vehicle: vIGA-ADTM response rates were 45.4% vs 13.9% and 46.4% vs 18.0% (both P<0.0001); EASI75 response rates were 55.8% vs 22.9% and 59.1% vs 21.2% (both P<0.0001); and a ≥4-point reduction in PP-NRS was achieved by 55.8% vs 34.2% (P=0.0366) and 52.8% vs 24.1% (P=0.0015), in ADORING 1 and 2, respectively. AEs were mostly mild or moderate; the most frequent (≥5% in any group) were folliculitis, headache, and nasopharyngitis. Trial discontinuation rates due to AEs were lower with tapinarof versus vehicle (ADORING 1: 1.9% vs 3.6%; ADORING 2: 1.5% vs 3.0%, respectively). Rates of AESIs with tapinarof versus vehicle were: contact dermatitis 1.5% vs 2.2% and 1.1% vs 1.5%; follicular events 10.0% vs 0.7% and 8.9% vs 1.5%; and headache 7.0% vs 2.2% and 1.5% vs 0%, in each trial, respectively. Conclusions Tapinarof cream 1% QD demonstrated statistically significant efficacy compared with vehicle for primary and secondary efficacy endpoints in adults and children down to 2 years of age with AD. Tapinarof was well tolerated, with no new safety or tolerability signals. AEs were mostly mild to moderate and led to low rates of trial discontinuation, demonstrating the predictable safety profile of tapinarof cream 1% QD.

Drug rashes are common. Almost 3% of children treated with a drug and up to 12% of children treated with an antibiotic will experience a drug rash. Most of the time, the rash is benign. This type of rash is often referred to as "morbilliform" or "maculopapular." A typical history for a morbilliform rash is that the child starts a course of an antibiotic for a bacterial infection, and then around day 7 to 10 the rash appears. It is characterized by erythematous macules and papules that can coalesce into plaques on the face, trunk, and extremities (Figure 16-1). The child is afebrile (assuming the bacterial infection has been adequately treated), feels fine, but looks terrible because of the rash. Withdrawal of the drug is the treatment of choice. Often times the child can finish the remaining doses of antibiotic without any damage but in some cases the rash can progress to erythroderma with superficial desquamation. Sometimes it can be difficult to differentiate a viral rash from a drug rash. In these cases, timing of drug exposure is important but also appearance of the rash. Often viral rashes can have slightly smaller papules (even pin-point in some cases) compared to larger papules in a morbilliform drug eruption. Also there is often a greater coalescing of papules in dependent areas (back and buttocks) in morbilliform medication eruptions. Topical steroids and oral antihistamines can be used if pruritus is a problem. Figure 16-1 Erythematous macules and papules on the arm of a patient with a morbilliform drug reaction. https://s3-euw1-ap-pe-df-pch-content-public-p.s3.eu-west-1.amazonaws.com/9781003523628/fea5ccf3-1b7d-4202-9c72-5311a5b42bf3/content/fig16-1.jpg" xmlns:xlink="https://www.w3.org/1999/xlink"/>

Background: An out-of-office therapeutic agent indicated for molluscum contagiosum is needed. Objective: To assess the efficacy and safety of berdazimer gel, 10.3% (a topical, antiviral, nitric oxideereleasing medication) versus vehicle. Methods: Berdazimer gel, 10.3% or vehicle was applied once daily to all molluscum contagiosum lesions for 12 weeks in patients $6 months with 3-70 mollusca. Efficacy assessment: complete lesion clearance and partial clearance at week 12. Safety and tolerability assessment: adverse events through week 24 and local skin reactions through week 12. Results: There were 1598 patients enrolled (n = 917 berdazimer, n = 681 vehicle). Berdazimer was superior to vehicle at week 12 in complete clearance rates, 30.0% versus 19.8% (odds ratio, 1.75; 95% CI, 1.38-2.23, P \ .001). Subgroup analyses of primary efficacy showed consistent favorable efficacy for berdazimer across most subgroups, including age, sex, baseline lesion count, and disease duration. Berdazimer provided favorable outcome for partial clearance. Application-site pain (18.7% vs 4.8% in berdazimer vs vehicle) and erythema (11.7% vs 1.3%), mostly mild to moderate, were the most common local skin reactions. Limitations: Berdazimer sodium in molluscum patients with lesions (B -SIMPLE) trials enrolled only US patients; no efficacy assessments beyond week 12. Conclusions: Berdazimer gel, 10.3% showed favorable efficacy and safety across subgroups. ( J Am Acad Dermatol 2024;90:299-308.)

Fibroblastic connective tissue nevus (FCTN) is a rare, benign dermal mesenchymal lesion of fibroblastic and myofibroblastic lineage. We report a case of a 2-year-old male who presented with an 18-month history of an erythematous, asymptomatic, unchanging dermal plaque on the right medial frontal scalp. A punch biopsy showed a disorderly, bland, dermal fibroblastic spindle cell proliferation extending to the superficial subcutis. It stained positive for CD34, and concern for dermatofibrosarcoma protuberans was raised. However, FISH was negative for PDGFB rearrangement, and the constellation of findings was most consistent with FCTN. This case underscores the importance of distinguishing CD34+ mesenchymal tumors for both dermatologists and dermatopathologists. As these represent a rather diverse group of lesions with different biological behaviors, a knowledge of the differential diagnosis of these entities is critical for proper patient management.

Travis Park Dermatology Clinic is a student-run free clinic serving uninsured patients primarily from Bexar County where the postsecondary education rate is below the national average. Dermatological procedures performed in clinic often result in superficial wounds, highlighting the need for proper wound care education. This study, rooted in American Academy of Dermatology (AAD) guidelines, aimed to evaluate wound care knowledge of patients receiving care at our clinic. Surveys were administered to patients aged 18 and older with a total of 27 responses. The survey featured five multiple-choice questions exploring various aspects of wound care, alongside a 5-point Likert scale rating question gauging participants' confidence in their wound care knowledge. A one-tailed T-test was used to analyze the multiple choice questions, assuming that three out of four correct answers indicated sufficient knowledge. While the average confidence rating was 4.33 out of 5 on the Likert scale, deeper analysis revealed that only 7.40% (n=2) adhered to current AAD guidelines. Approximately 51.85% (n=14) correctly identified all characteristics of an infected wound, and 66.70% (n=18) recognized the use of mild soap and water for cleaning wounds. However, only 14.81% (n=4) knew that wounds should be kept moist. When assessing multiple-choice questions, 37.03% (n=10) demonstrated sufficient wound care knowledge (p<0.0005). Our study highlights the importance of patient wound care education. The clinic now provides patients with AAD guideline-based wound care recommendation sheets post-procedure in hopes to enhance wound healing and reduce complications.

Introduction: Travis Park Dermatology Clinic is a free clinic that treats our community's homeless and uninsured populations. These patients face multiple barriers to care, including language barriers, transportation challenges, financial constraints, and low health literacy.

Although dermatological conditions are one of the leading causes of disease burden within the United States, there is a lack of dedicated medical education in treating common skin conditions. Many pre- clinical medical students expressed low confidence in conducting patient interviews and performing focused skin exams. Travis Park Dermatology Clinic is a student-run free clinic in San Antonio, TX that provides dermatologic care to underserved communities. From April 2022 to September 2022, a volunteer training PowerPoint presentation was given to 40 medical students prior to volunteering at Travis Park. Pre-and post-surveys assessing volunteer confidence in describing skin lesions and performing skin exams were administered before and after the presentation. Qualitative responses were converted into a 4-point Likert scale, and a Wilcoxon signed-rank test was used for analysis. A total of 29 pre-clinical medical student survey responses were used for data analysis: 20 were from MS2s, and 9 were from MS1s. After volunteering, there were significant increases in knowledge describing skin lesions (P<0.001), comfort in describing skin lesions to faculty dermatologists using appropriate morphologic terminology (P<0.001), and comfort in obtaining focused skin histories and examinations (P<0.001). The five-item quiz score improvement was also significant (P<0.001); the mean number of correct answers was 2.48 (SD = 1.43) before the presentation and 4.62 (SD = 0.62) after. Our intervention may aid in providing basic dermatology education and clinical skills to improve pre-clinical student confidence, knowledge, and learning experience while at Travis Park.

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.

The most common bacteria isolated from wound cultures in patients recorded in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database (EBCCOD) are Staphylococcus aureus and Pseudomonas aeruginosa. Given the prevalence of P. aeruginosa in this patient population and prior research implicating P. aeruginosa's potential role in carcinogenesis, we sought to further analyze patients with recorded wound cultures positive for Pseudomonas aeruginosa in the EBCCOD. We provide a descriptive analysis of this subset of patients and highlight potential avenues for future longitudinal studies that may have significant implications in our wound care management for patients with epidermolysis bullosa.

Background: Berdazimer gel 10.3% is a topical nitric oxide releasing medication in Phase 3 development for the treatment of molluscum contagiosum. Objective: To assess the safety of berdazimer gel 10.3% in three phase 3 molluscum studies B-SIMPLE 1, 2 and 4 (NCTs: 03927716, 03927703, 04535531).