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NCT04845620 · ClinicalTrials.gov registry record · Phase 3
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
A Phase 3 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 652
- Enrollment target
NCT04845620: Completed Phase 3 study, sponsored by Arcutis Biotherapeutics.
NCT04845620 is a Phase 3 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 652 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04845620, a Phase 3 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 652 participants
- Enrollment target
Study Summary
This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
Primary Outcome
The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
Interventions
- DRUG Vehicle Cream
- DRUG Roflumilast Cream 0.05%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2021-04-07 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 3 |
What the finished NCT04845620 record still lists
NCT04845620 is an interventional study that assigns participants to a tested intervention. The registered 652 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 (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Cream is the first listed.
NCT04845620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04845620 about?
NCT04845620 is a clinical study titled "Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)". This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
What is the current status of trial NCT04845620?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2021-04-07. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04845620?
The interventions under investigation include: Vehicle Cream (DRUG), Roflumilast Cream 0.05% (DRUG).
Who is sponsoring clinical trial NCT04845620?
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 NCT04845620's enrollment target sits among peer trials
652 571st of 2000 higher than 1,429 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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