Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
Summary
This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.
Timeline
- Start
- 2021-07-08
- Primary completion
- 2022-04-06
- Completion
- 2022-04-06
Outcome
Met primary endpoint
registry Roflumilast Foam 0.3% vs Vehicle Foam; p <0.0001; Odds Ratio (OR) 2.79 (95% CI 1.75 to 4.45) NCT04973228 ↗
release “The STRATUM study met its primary endpoint” arcutis.com ↗
release “The STRATUM study met its primary endpoint, with nearly 80% of ZORYVE foam treated individuals reaching Investigator Global Assessment (IGA) Success rate at Week 8” arcutis.com ↗
release “The STRATUM study met its primary endpoint, with 80% of roflumilast foam treated individuals reaching IGA Success rate at Week 8” arcutis.com ↗
release “Significant improvement in signs and symptoms of seborrheic dermatitis with ZORYVE foam 0.3%, as measured by Investigator Global Assessment (IGA) Success at Week 8” arcutis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roflumilast | Small molecule | 0.3 % | Topical |