Efficacy and Patient-Reported Outcomes from a Phase IIb, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Adolescents and Adults with Atopic Dermatitis
Paller AS, Gold LS, Soung J, Tallman AM, Rubenstein DS, and Gooderham M. Efficacy and Patient-Reported Outcomes from a Phase IIb, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Adolescents and Adults with Atopic Dermatitis. J Am Acad Dermatol 2020.
Journal of the American Academy of Dermatology
BACKGROUND: Tapinarof is a topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) under investigation for atopic dermatitis (AD) and psoriasis treatment.
METHODS: Phase IIb, double-blind, vehicle-controlled study randomized adolescents and adults with AD to receive tapinarof cream 0.5%, 1%, or vehicle, once (QD) or twice daily (BID) for 12 weeks with 4-week follow-up. Outcomes included Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), body-surface area (BSA) affected, pruritus numeric rating scale scores, subject impressions of AD and pruritus symptom severity, and Patient-Oriented Eczema Measure (POEM) scores.
RESULTS: 191/247 randomized subjects completed the study. Week-12 IGA responses were higher in tapinarof groups vs vehicle, reaching statistical significance with tapinarof 1%BID; ≥75/90% improvement in EASI from baseline were significantly higher in tapinarof groups (except 0.5%QD and 0.5%BID, respectively); EASI scores were significantly improved in all tapinarof groups; BSA affected was significantly reduced in tapinarof groups (except 0.5%BID). More subjects reported AD and pruritus symptom severity as very/moderately improved in tapinarof groups and POEM improvements were observed in all groups. Most adverse events were mild or moderate.
LIMITATIONS: Larger prospective studies are required to confirm reported analyses.
CONCLUSIONS: Tapinarof is a potential important advance in topical medicine development for AD.
ePub ahead of print