Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

Summary

This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.

Timeline

Start

2019-05-21

Primary completion

2020-05-26

Completion

2020-05-26

Publications

• Results Lebwohl MG, Stein Gold L, Strober B, Papp KA, Armstrong AW, Bagel J, Kircik L, Ehst B, Hong HC, Soung J, Fromowitz J, Guenthner S, Piscitelli SC, Rubenstein DS, Brown PM, Tallman AM, Bissonnette R. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. N Engl J Med. 2021 Dec 9;385(24):2219-2229. doi: 10.1056/NEJMoa2103629.
• 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.
• Kircik L, Zirwas M, Kwatra SG, Lewitt GM, Glover H, Chao T, Brown PM, Rubenstein DS, Tallman AM. Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Jan;14(1):201-211. doi: 10.1007/s13555-023-01068-x. Epub 2023 Dec 21.
• Desai SR, Stein Gold L, Cameron MC, Golant A, Lewitt GM, Bruno MJ, Martin G, Brown PM, Rubenstein DS, Butners V, Tallman AM. Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. Dermatol Ther (Heidelb). 2023 Oct;13(10):2443-2460. doi: 10.1007/s13555-023-01008-9. Epub 2023 Sep 11.
• Grossmann MC, Pixley JN, Feldman SR. A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2024 Jan;58(1):76-85. doi: 10.1177/10600280231164775. Epub 2023 Apr 19.

Drugs

Indications