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

Outcome

Met primary endpoint

registry analysis (superiority test); Roflumilast Cream 0.15% vs Vehicle Cream; p <0.0001; Odds Ratio (OR) 2.96 (95% CI 1.881 to 4.647); Cochran-Mantel-Haenszel NCT04773587 ↗

release “INTEGUMENT-1: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001” arcutis.com ↗

release “Both studies met the primary endpoint of IGA Success” arcutis.com ↗

release “both INTEGUMENT-1 and -2 studies met their primary endpoint of IGA Success” arcutis.com ↗

release “INTEGUMENT-1: 32.0% ZORYVE cream vs. 15.2% vehicle, P<0.0001” arcutis.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Roflumilast	Small molecule	0.15 %	Topical

Indications