Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Arcutis Biotherapeutics, Inc.
- Study ID
- NCT04973228
- Phase
- PHASE3
- Status
- Completed
Conditions
- Seborrheic Dermatitis
Eligibility Criteria
- Sex
- ALL
- Age
- 9 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast Foam — DRUGRoflumilast 0.3% foam for topical application
- Vehicle Foam — DRUGVehicle foam for topical application
Study Details
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.
Key Dates
- Start date
- Jul 8, 2021
- Status verified
- Feb 2024
- Primary completion
- Apr 6, 2022
- Completion
- Apr 6, 2022
Study Design
- Enrollment
- 457 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Roflumilast Foam 0.3%Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.
- Placebo Comparator: Vehicle FoamParticipants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.
Primary Outcome Measure
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 [ Time Frame: Week 8 ]
Locations (43)
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