The study to assess the efficacy of difamilast ointment in mild to moderate AD

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The research company Acrotech Biopharma Inc is conducting a Phase 3 Double Blind multi-center study conducted at 40 US investigational sites to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.

The study sites are enrolling at multiple locations in the USA. It is planned to include 336 participants.

Actual study start date is October 1, 2022. The researchers expect to complete the study by December 30, 2023.

One primary outcome measure is 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 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, who have no use of prohibited medication, and who do not discontinue treatment due to related AE or lack of efficacy.

The location of the study can be found here: https://ichgcp.net/clinical-trials-registry/NCT05608343.

 

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