Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Summary

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

Timeline

Start

2021-01-27

Primary completion

2022-08-30

Completion

2022-08-30

Publications

• Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121.

Drugs

Indications