Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials

Authors

Linda Stein Gold, Henry Ford Health System, Detroit, MI, USA.
James Del Rosso, JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV, USA.
Benjamin D. Ehst, Oregon Medical Research Center, Portland, OR, USA.
Matthew J. Zirwas, DOCS Dermatology, Bexley, OH, USA.
Lawrence J. Green, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Philip M. Brown, Dermavant Sciences, Inc., Morrisville, NC, USA.
David S. Rubenstein, Formerly of Dermavant Sciences, Inc, Morrisville, NC, USA.
Stephen C. Piscitelli, Dermavant Sciences, Inc., Morrisville, NC, USA.
Anna M. Tallman, Dermavant Sciences, Inc., Morrisville, NC, USA.

Document Type

Journal Article

Publication Date

12-1-2025

Journal

The Journal of dermatological treatment

Volume

36

Issue

1

DOI

10.1080/09546634.2024.2444489

Keywords

Tapinarof cream 1% once daily; adults and children; aryl hydrocarbon receptor agonist; atopic dermatitis; local tolerability scale; phase 3 trials

Abstract

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes. Patients received Tapinarof or vehicle cream QD for 8 weeks. Tolerability was evaluated using patient/parent/caregiver and investigator 5-point Local Tolerability Scales (LTS). Investigators assessed tolerability for sensitive skin areas, including face/neck. 813 patients were randomized (∼80% pediatric). Mean pretreatment baseline overall LTS scores were similar across groups and trials: 1.0-1.9 (patient-assessed) indicating slight burning/stinging and itching; and 0.3-0.6 (investigator-assessed) indicating no-to-minimal irritation. Tapinarof was well tolerated with improvement from pretreatment baseline and no-to-minimal burning/stinging and itching from first application through Week 8 (patient-reported): mean Week 8 LTS scores were 0.2-0.4 (burning/stinging) and 0.6-0.8 (itching). Investigators reported improvement from pretreatment baseline with no-to-minimal irritation (dryness/erythema/peeling) from first Tapinarof application through Week 8 (mean LTS scores: 0.2 and 0.1 in ADORING 1 and 2, respectively). Across sensitive skin, investigators reported no-to-minimal irritation from first application through Week 8 (mean scores [Tapinarof versus vehicle]: 0-0.3 versus 0-1.0). Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas. NCT05014568, NCT05032859.

APA Citation

Gold, Linda Stein; Del Rosso, James; Ehst, Benjamin D.; Zirwas, Matthew J.; Green, Lawrence J.; Brown, Philip M.; Rubenstein, David S.; Piscitelli, Stephen C.; and Tallman, Anna M., "Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials" (2025). GW Authored Works. Paper 6287.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/6287

Department

Dermatology