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NCT04773600 · ClinicalTrials.gov registry record · Phase 3
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
A Phase 3 study, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 683
- Enrollment target
NCT04773600: Completed Phase 3 study, sponsored by Arcutis Biotherapeutics.
NCT04773600 is a Phase 3 study that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 683 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04773600, a Phase 3 study, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 683 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.
Primary Outcome
The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity
Interventions
- DRUG Vehicle cream
- DRUG Roflumilast Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 683 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2022-09-29 |
| Phase | Phase 3 |
What the finished NCT04773600 record still lists
NCT04773600 is an interventional study that assigns participants to a tested intervention. The registered 683 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 (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle cream is the first listed.
NCT04773600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04773600 about?
NCT04773600 is a clinical study titled "Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)". This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by pa...
What is the current status of trial NCT04773600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 683 participants. The study started on 2021-02-24. Estimated completion is 2022-09-29.
What interventions are being tested in trial NCT04773600?
The interventions under investigation include: Vehicle cream (DRUG), Roflumilast Cream (DRUG).
Who is sponsoring clinical trial NCT04773600?
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 NCT04773600's enrollment target sits among peer trials
683 529th of 2000 higher than 1,472 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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