Roflumilast Cream 0.05%

DRUG2 trials

Sponsors

Arcutis Biotherapeutics, Inc.

Conditions

Atopic DermatitisAtopic Dermatitis Eczema

Phase 2

Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

CompletedNCT03916081

Arcutis Biotherapeutics, Inc.Atopic Dermatitis

Start: 2019-05-31End: 2019-11-04Updated: 2023-02-13

Phase 3

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

CompletedNCT04845620

Arcutis Biotherapeutics, Inc.Atopic Dermatitis Eczema

Start: 2021-04-07End: 2023-06-01Updated: 2025-12-23

Related Papers

Once-daily Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Patients Aged 2–5 Years With Diverse Skin Types: Subgroup Analysis From the Phase 3 INTEGUMENT-PED Trial

SKIN The Journal of Cutaneous Medicine2026-03-10

Long‐Term Safety and Efficacy of Once‐Daily and Proactive Twice‐Weekly Roflumilast Cream 0.05% for Mild‐to‐Moderate Atopic Dermatitis in Children Aged 2–5 Years From a 52‐Week, Phase 3 Trial ( <scp>INTEGUMENT</scp> ‐ <scp>OLE</scp> )

Pediatric Dermatology2026-03-08

Efficacy and Safety of Once‐Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2–5 Years With Mild‐to‐Moderate Atopic Dermatitis ( <scp>INTEGUMENT</scp> ‐ <scp>PED</scp> ): A Phase 3 Randomized Controlled Trial

Pediatric Dermatology2025-02-204 citations

Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children

JAMA Dermatology2024-09-1841 citations

639 - Efficacy and safety of once-daily roflumilast cream 0.05% in pediatric patients 2 to 5 years of age with mild to moderate atopic dermatitis (INTEGUMENT-PED): a phase 3 randomized controlled trial

British Journal of Dermatology2024-08-013 citations

The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Patients With Atopic Dermatitis: Randomized, Double-Blind, Phase 2 Proof of Concept Study

Journal of Drugs in Dermatology2023-01-0142 citations