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NCT03916081 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis
A Phase 2 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
NCT03916081: Completed Phase 2 study, sponsored by Arcutis Biotherapeutics.
NCT03916081 is a Phase 2 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03916081, a Phase 2 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
Study Summary
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
Primary Outcome
The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score rang
Interventions
- DRUG Vehicle Cream
- DRUG Roflumilast Cream 0.15%
- DRUG Roflumilast Cream 0.05%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2019-05-31 |
| Est. Completion | 2019-11-04 |
| Phase | Phase 2 |
What the finished NCT03916081 record still lists
NCT03916081 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Vehicle Cream is the first listed.
NCT03916081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03916081 about?
NCT03916081 is a clinical study titled "Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis". The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
What is the current status of trial NCT03916081?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2019-05-31. Estimated completion is 2019-11-04.
What interventions are being tested in trial NCT03916081?
The interventions under investigation include: Vehicle Cream (DRUG), Roflumilast Cream 0.15% (DRUG), Roflumilast Cream 0.05% (DRUG).
Who is sponsoring clinical trial NCT03916081?
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 NCT03916081's enrollment target sits among peer trials
136 527th of 2000 higher than 1,469 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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