Trials / Completed
CompletedNCT05608343
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Difamilast Ointment 1% in Children, Adolescents, and Adults With Mild to Moderate Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Acrotech Biopharma Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Difamilast | Off-white ointment containing active ingredient, petrolatum and other ingredients |
| DRUG | Placebo | Matching Difamilast (Study drug) ointment without active ingradient |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2023-10-27
- Completion
- 2023-10-27
- First posted
- 2022-11-08
- Last updated
- 2024-08-15
Locations
39 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05608343. Inclusion in this directory is not an endorsement.