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NCT04973228 · ClinicalTrials.gov registry record · Phase 3
Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
A Phase 3 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 457
- Enrollment target
NCT04973228: Completed Phase 3 study, sponsored by Arcutis Biotherapeutics.
NCT04973228 is a Phase 3 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 457 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04973228, a Phase 3 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 457 participants
- Enrollment target
Study 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.
Primary Outcome
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
Interventions
- DRUG Vehicle Foam
- DRUG Roflumilast Foam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 3 |
What the finished NCT04973228 record still lists
NCT04973228 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Foam is the first listed.
NCT04973228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04973228 about?
NCT04973228 is a clinical study titled "Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)". 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.
What is the current status of trial NCT04973228?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 457 participants. The study started on 2021-07-08. Estimated completion is 2022-04-06.
What interventions are being tested in trial NCT04973228?
The interventions under investigation include: Vehicle Foam (DRUG), Roflumilast Foam (DRUG).
Who is sponsoring clinical trial NCT04973228?
This trial is sponsored by Arcutis Biotherapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04973228's enrollment target sits among peer trials
457 827th of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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