A Phase 3, Randomized, Double-Blind Study to Assess the Efficacy of Difamilast Ointment in Mild to Moderate AD

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acrotech Biopharma Inc.

Criteria

Important Inclusion Criteria:

1. Subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) provide written informed consent in accordance with federal and/or local laws prior to the conduct of any study-related procedures.

2. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria for at least 6 months

3. Subjects who have AD involvement ≥5% to ≤40% of treatable body BSA

4. Subjects who have an AD Severity of mild (2) or moderate (3) as measured by the IGA of AD Severity score

5. Subjects who are male or female ≥2 years of age

Etc.,

Important Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding or who plan to become pregnant

2. Subjects who have evidence of spontaneous clearance of AD

3. Subjects who have a history of unstable AD as assessed by the Investigator.

4. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD

5. Subject with depression and suicidal ideation

6. Subjects with a known history of alcohol abuse or illicit drugs

Etc.,

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