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NCT04445987 · ClinicalTrials.gov registry record · Phase 2
Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
A Phase 2 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 408
- Enrollment target
NCT04445987: Completed Phase 2 study, sponsored by Arcutis Biotherapeutics.
NCT04445987 is a Phase 2 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 408 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (207% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04445987, a Phase 2 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 408 participants
- Enrollment target
Study Summary
This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.
Primary Outcome
The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study re
Interventions
- DRUG ARQ-154
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2022-11-19 |
| Phase | Phase 2 |
What the finished NCT04445987 record still lists
NCT04445987 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (207% higher).
The record links to 0 conditions, and to 1 intervention - of which ARQ-154 is the first listed.
NCT04445987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04445987 about?
NCT04445987 is a clinical study titled "Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis". This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) a...
What is the current status of trial NCT04445987?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 408 participants. The study started on 2020-06-12. Estimated completion is 2022-11-19.
What interventions are being tested in trial NCT04445987?
The interventions under investigation include: ARQ-154 (DRUG).
Who is sponsoring clinical trial NCT04445987?
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 NCT04445987's enrollment target sits among peer trials
408 93rd of 2000 higher than 1,908 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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