Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials
Recommended Citation
Gold LS, Del Rosso J, Ehst BD, Zirwas MJ, Green LJ, Brown PM, Rubenstein DS, Piscitelli SC, and Tallman AM. Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials. J Dermatolog Treat 2025; 36(1):2444489.
Document Type
Article
Publication Date
1-12-2025
Publication Title
The Journal of dermatological treatment
Abstract
Background: 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.
Methods: 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.
Results: 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).
Conclusion: Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas. Clinicaltrials.gov numbers NCT05014568, NCT05032859.
Medical Subject Headings
Humans; Dermatitis, Atopic; Female; Male; Adult; Child; Child, Preschool; Adolescent; Skin Cream; Treatment Outcome; Double-Blind Method; Young Adult; Middle Aged; Severity of Illness Index; Administration, Cutaneous; Pruritus; Resorcinols; Stilbenes
PubMed ID
39799945
Volume
36
Issue
1
First Page
2444489
Last Page
2444489
