drugset / Trial / NCT04845620
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
RandomizedParallel-groupTriple-blindTreatment
Summary
This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
Timeline
- Start
- 2021-04-07
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
Outcome
Met primary endpoint
registry analysis (superiority test); Roflumilast Cream 0.05% vs Vehicle Cream; p <0.0001; Odds Ratio (OR) 2.89 (97.5% CI 1.648 to 5.064); Cochran-Mantel-Haenszel NCT04845620 ↗
paper significantly greater proportions of the roflumilast group achieved Week-4 vIGA-AD Success (25.4% vs. 10.7%; p < 0.0001) PMID 39980188 ↗
Publications
- Eichenfield LF, Gonzalez ME, Boguniewicz M, Funk T, Hebert AA, Prajapati VH, Kindred C, Serrao R, Swanson L, Krupa D, Snyder S, Seal MS, Hanna D, Burnett P, Berk DR. 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 (INTEGUMENT-OLE). Pediatr Dermatol. 2026 May-Jun;43(3):642-649. doi: 10.1111/pde.70177. Epub 2026 Mar 8.
- Eichenfield LF, Serrao R, Prajapati VH, Browning JC, Swanson L, Funk T, Gonzalez ME, Hebert AA, Lee M, Boguniewicz M, Simpson EL, Seal MS, Krupa D, Hanna D, Snyder S, Burnett P, Chu DH, Almaraz E, Higham RC, Berk DR. Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial. Pediatr Dermatol. 2025 Mar-Apr;42(2):296-304. doi: 10.1111/pde.15840. Epub 2025 Feb 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roflumilast | Small molecule | 0.05 % | Topical |