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NCT05608343 · ClinicalTrials.gov registry record · Phase 3
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
A Phase 3 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT05608343: Completed Phase 3 study, sponsored by Acrotech Biopharma.
NCT05608343 is a Phase 3 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05608343, a Phase 3 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study Summary
This is a Phase 3 Double Blind multi-center study conducted at 40 investigational sites in United States to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.
Primary Outcome
The proportion of subjects achieving success on the the 5-point Investigator Global Assessment (IGA) of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29
Interventions
- DRUG Placebo
- DRUG Difamilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2023-10-27 |
| Phase | Phase 3 |
What the finished NCT05608343 record still lists
NCT05608343 is an interventional study that assigns participants to a tested intervention. The registered 153 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05608343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05608343 about?
NCT05608343 is a clinical study titled "This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)". This is a Phase 3 Double Blind multi-center study conducted at 40 investigational sites in United States to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.
What is the current status of trial NCT05608343?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2022-10-01. Estimated completion is 2023-10-27.
What interventions are being tested in trial NCT05608343?
The interventions under investigation include: Placebo (DRUG), Difamilast (DRUG).
Who is sponsoring clinical trial NCT05608343?
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 NCT05608343's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 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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