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NCT05028582 · ClinicalTrials.gov registry record · Phase 3
Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
A Phase 3 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 432
- Enrollment target
NCT05028582: Completed Phase 3 study, sponsored by Arcutis Biotherapeutics.
NCT05028582 is a Phase 3 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 432 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05028582, a Phase 3 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 432 participants
- Enrollment target
Study Summary
This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.
Primary Outcome
The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Interventions
- DRUG Vehicle Foam
- DRUG Roflumilast Foam 0.3%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2022-06-03 |
| Phase | Phase 3 |
What the finished NCT05028582 record still lists
NCT05028582 is an interventional study that assigns participants to a tested intervention. The registered 432 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 (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Foam is the first listed.
NCT05028582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05028582 about?
NCT05028582 is a clinical study titled "Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)". This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.
What is the current status of trial NCT05028582?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 432 participants. The study started on 2021-08-24. Estimated completion is 2022-06-03.
What interventions are being tested in trial NCT05028582?
The interventions under investigation include: Vehicle Foam (DRUG), Roflumilast Foam 0.3% (DRUG).
Who is sponsoring clinical trial NCT05028582?
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 NCT05028582's enrollment target sits among peer trials
432 876th of 2000 higher than 1,124 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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