A Phase 3 interventional study of Difamilast and Placebo in Atopic Dermatitis, sponsored by Acrotech Biopharma Inc.. Completed at 39 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Acrotech Biopharma Inc. · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 153 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Acrotech Biopharma Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Important Inclusion Criteria:
Important Exclusion Criteria:
Etc.,
1% Difamilast Ointment
Drug: Difamilast
Matching placebo
Drug: Placebo
Off-white ointment containing active ingredient, petrolatum and other ingredients
Matching Difamilast (Study drug) ointment without active ingradient
To evaluate the efficacy of twice-daily topical application of Difamilast ointment 1% compared to vehicle control in subjects ≥2 years of age with mild to moderate AD
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
Time frame: Baseline, Day 29
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
The proportion of subjects achieving an IGA of AD Severity score of Clear (0) or Almost clear (1) at Day 29; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15
Time frame: Baseline, Day 15, Day 22 and Day 29
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Acrotech Biopharma Inc.