Abbreviations used:AD (atopic dermatitis), AE (adverse event), BSA (body surface area), IGA (Investigator Global Assessment), EASI (Eczema Area and Severity Index), EASI75 (≥75% improvement in Eczema Area and Severity Index from baseline), EASI90 (≥90% improvement in Eczema Area and Severity Index from baseline), ITT (intent-to-treat), NRS (numeric rating scale), POEM (Patient-Oriented Eczema Measure), PRO (patient-reported outcome)
- •Tapinarof, a topical therapeutic aryl hydrocarbon receptor–modulating agent, was efficacious and well tolerated in adolescents and adults with atopic dermatitis (AD).
- •Tapinarof cream has the potential to provide a novel and clinically meaningful therapeutic option for AD with a unique mechanism of action distinct from currently available AD therapies.
Outcome measures and statistical analysis
Primary efficacy endpoint
Safety and tolerability
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Funding sources: Supported by Dermavant Sciences, Inc .
Disclosure: Dr Paller is an investigator (without personal compensation) for AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, LEO Pharma, Janssen, Novartis, and Sanofi-Regeneron and a consultant (with honoraria) for AbbVie, Amgen, Asana, Dermavant Sciences, Inc, Dermira, Galderma, Eli Lilly, Forte, LEO Pharma, Matrisys, Menlo, MorphoSys/Galapagos, Novartis, Pfizer, and Sanofi-Regeneron. Dr Stein Gold is an investigator, consultant, and speaker with honoraria for Galderma, LEO Pharma, Ortho Dermatologics, and Pfizer Inc; an investigator with research grants for Incyte , AbbVie , and Eli Lily ; a consultant and speaker with honoraria for Mayne and Taro; and a consultant with honoraria and an investigator for Dermavant Sciences, Inc. Dr Soung has received research grants and/or honoraria as an investigator for AbbVie , Actavis , Actelion , Allergan , Boehringer Ingelheim , Cassiopea , Dermira , Eli Lilly , Galderma , Janssen , Kadmon Corporation , Kyowa Kirin , LEO Pharma , Menlo , Ortho Dermatologics , Pfizer , and UCB ; an investigator and consultant for Novartis and Dermavant Sciences, Inc; a speaker for AbbVie, Actelion, Amgen Inc, Celgene Corporation, Dermira, Eli Lilly, the National Psoriasis Foundation (nonprofit), Novartis, Ortho Dermatologics, and Regeneron; and an advisor for Eli Lilly and LEO Pharma. Dr Tallman is an employee of Dermavant Sciences, Inc, with stock options. Dr Rubenstein is an employee of Dermavant Sciences, Inc, with stock options. Dr Gooderham has been an investigator, speaker, advisory board member, or consultant for AbbVie, Amgen, Akros, Arcutis, Bausch Health, Boehringer Ingelheim, Celgene, Dermavant Sciences, Inc, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and UCB.
IRB approval status: Approval was obtained from the local ethics committee or IRB at each study center.
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