This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: Difamilast

• Registration Number: NCT05608343
• Lead Sponsor: Acrotech Biopharma Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-08
• Primary Completion: 2023-10-27
• Study Completion: 2023-10-27
• Disposition First Posted: 2023-11-28
• Status Verified: 2024-08
• Disposition First Submitted: 2024-08-13
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

1. Subjects who are male or female ≥2 years of age
2. 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.
3. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
4. Subjects who have had a diagnosis of AD for at least 6 months prior to Screening visit
5. Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
6. Subjects who have an AD Severity of mild (2) or moderate (3) as measured by the IGA of AD Severity score at screening and baseline visit

Important

Exclusion Criteria

1. Female subjects who are pregnant or breastfeeding or who plan to become pregnant during the study and through 90 days after the last dose of study drug
2. Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
3. Subjects who have a history of unstable AD as assessed by the Investigator. Unstable AD is defined as disease flares occurring within 4 weeks prior to baseline visit
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 greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
6. Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening

Etc.,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Vehicle Controlled	Placebo	Matching placebo
Difamilast Ointment	Difamilast	1% Difamilast Ointment

Primary Outcome Measures

Name	Time	Method
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	Baseline, Day 29	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

Secondary Outcome Measures

Name	Time	Method
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD	Baseline, Day 15, Day 22 and Day 29	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

Trial Locations

Locations (38)

AllerVie Health; 🇺🇸 Birmingham, Alabama, United States

Elite Clinical Studies, LLC; 🇺🇸 Phoenix, Arizona, United States

NEA Baptist Clinic-Dermatology; 🇺🇸 Jonesboro, Arkansas, United States

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Antelope Valley Clinical Trials; 🇺🇸 Lancaster, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Shahram Jacobs, MD Inc.; 🇺🇸 Sherman Oaks, California, United States

Clinical Trials Research Institute; 🇺🇸 Thousand Oaks, California, United States

IMMUNOe Research Centers; 🇺🇸 Centennial, Colorado, United States

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