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NCT05571943 · ClinicalTrials.gov registry record · Phase 3
A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis
A Phase 3 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 542
- Enrollment target
NCT05571943: Completed Phase 3 study, sponsored by Acrotech Biopharma.
NCT05571943 is a Phase 3 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 542 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05571943, a Phase 3 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 542 participants
- Enrollment target
Study Summary
This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.
Interventions
- DRUG Difamilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 542 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 3 |
What the finished NCT05571943 record still lists
NCT05571943 is an interventional study that assigns participants to a tested intervention. The registered 542 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 (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Difamilast is the first listed.
NCT05571943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05571943 about?
NCT05571943 is a clinical study titled "A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis". This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.
What is the current status of trial NCT05571943?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 542 participants. The study started on 2022-09-15. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT05571943?
The interventions under investigation include: Difamilast (DRUG).
Who is sponsoring clinical trial NCT05571943?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05571943's enrollment target sits among peer trials
542 694th of 2000 higher than 1,307 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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