Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)

Summary

This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.

Timeline

Start

2021-09-23

Primary completion

2023-02-03

Completion

2023-02-08

Outcome

Met primary endpoint

registry NUMBER Tapinarof Cream: 46.4 Percentage of participants NCT05032859 ↗

registry analysis (superiority test); Tapinarof Cream vs Vehicle Cream; p <0.0001; Risk Ratio, log 2.27 (95% CI 1.54 to 3.32); Cochran-Mantel-Haenszel NCT05032859 ↗

release “In ADORING 2 (N=406), VTAMA cream met the primary endpoint of the trial” organon.com ↗

Publications

• Results Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.
• Alexis AF, Kircik L, Chovatiya R, Rice ZP, Soong W, Bhutani T, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM, Armstrong AW. Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials. Dermatol Ther (Heidelb). 2025 Sep;15(9):2667-2682. doi: 10.1007/s13555-025-01489-w. Epub 2025 Jul 22.
• Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.
• Bissonnette R, Stein Gold L, Kircik L, Simpson EL, Eichenfield LF, Browning J, Hebert AA, Alexis AF, Soong W, Piscitelli SC, Tallman AM, Rubenstein DS, Brown PM, Silverberg JI. Skin clearance, duration of treatment-free interval, and safety of tapinarof cream 1% once daily: Results from ADORING 3, a 48-week phase 3 open-label extension trial in adults and children down to 2 years of age with atopic dermatitis. J Am Acad Dermatol. 2025 Sep;93(3):707-714. doi: 10.1016/j.jaad.2025.05.1391. Epub 2025 May 16.
• Gold LS, Del Rosso J, Ehst BD, Zirwas MJ, Green LJ, Brown PM, Rubenstein DS, Piscitelli SC, 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 Dec;36(1):2444489. doi: 10.1080/09546634.2024.2444489. Epub 2025 Jan 12.
• Simpson EL, Hebert AA, Browning J, Serrao RT, Sofen H, Brown PM, Piscitelli SC, Rubenstein DS, Tallman AM. Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children. Dermatol Ther (Heidelb). 2025 Jan;15(1):111-124. doi: 10.1007/s13555-024-01318-6. Epub 2025 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tapinarof	Other / unclassified	1 %	Topical

Indications