AUTHOR=Igarashi Atsuyuki , Tsuji Gaku , Murata Ryusei , Fukasawa Shuichi , Yamane Satoshi 
  
TITLE=Efficacy and safety of tapinarof cream once daily in Japanese pediatric patients with atopic dermatitis: a 60-week phase 3 trial consisting of an 8-week, double-blind, vehicle-controlled period and a 52-week, open-label extension period
  
JOURNAL=Journal of Cutaneous Immunology and Allergy
  
VOLUME=Volume 9 - 2026
  
YEAR=2026
  
URL=https://www.frontierspartnerships.org/journals/journal-of-cutaneous-immunology-and-allergy/articles/10.3389/jcia.2026.17307
  
DOI=10.3389/jcia.2026.17307
  
ISSN=2574-4593
  
ABSTRACT=BackgroundIn Japan, tapinarof cream (an aryl hydrocarbon receptor agonist) is approved for the treatment of atopic dermatitis (AD) in patients aged ≥12 years.MethodsIn Japanese pediatric patients aged 2–11 years with AD, we conducted a 60-week phase 3 trial of tapinarof cream, consisting of an 8-week, double-blind, vehicle-controlled period (DB period) and a 52-week, open-label extension period (OL period). Eligible patients (N = 162) were randomized to tapinarof cream 0.5% (n = 107) or vehicle cream (n = 55) in the DB period; subsequently, all patients who entered the OL period (n = 151) received tapinarof cream 0.5%.ResultsAt week 8 in the DB period, the proportion of patients with ≥75% improvement from baseline in Eczema Area and Severity Index (EASI) score (EASI-75 response, the primary endpoint) was significantly higher in the tapinarof group than in the vehicle group (52.59% vs. 12.60%, p < 0.0001). The proportion of patients who achieved an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) with ≥ 2-grade improvement from baseline at week 8 (IGA treatment success, a key secondary endpoint) was 26.2% in the tapinarof group and 1.8% in the vehicle group. In the OL period, improvements in efficacy endpoints continued through week 60 with treatment. In the tapinarof group, EASI-75 response rate was 75.8% at week 32% and 80.2% at week 60, and IGA treatment success rate was 48.5% at week 32, and 56.3% at week 60. Across the DB and OL periods, no treatment-related serious adverse events (AEs) were reported, and all treatment-related AEs were mild or moderate. The most common treatment-related AEs included folliculitis and acne.ConclusionTapinarof cream was effective and well tolerated for up to 60 weeks in the treatment of Japanese pediatric patients aged 2–11 years with AD.