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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608343
• Other study ID #: MM36-301
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2022
• Est. completion date: October 27, 2023

Study information

• Verified date: November 2023
• Source: Acrotech Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Important 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.,

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Difamilast
Off-white ointment containing active ingredient, petrolatum and other ingredients
• Placebo
Matching Difamilast (Study drug) ointment without active ingradient

Locations

Country	Name	City	State
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Oakland Hills Dermatology, PC	Auburn Hills	Michigan
United States	Bexley Dermatology Research	Bexley	Ohio
United States	AllerVie Health	Birmingham	Alabama
United States	Optima Research	Boardman	Ohio
United States	TrueBlue Clinical Research	Brandon	Florida
United States	Metro Boston Clinical Partners	Brighton	Massachusetts
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	DS Research	Clarksville	Indiana
United States	Remington-Davis, Inc.	Columbus	Ohio
United States	Avant Research Associates, LLC	Crowley	Louisiana
United States	Accel Research - Edgewater Clinical Research Unit	Edgewater	Florida
United States	First OC Dermatology	Fountain Valley	California
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina
United States	Center for Clinical Studies, Ltd, LLP	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	NEA Baptist Clinic-Dermatology	Jonesboro	Arkansas
United States	Antelope Valley Clinical Trials	Lancaster	California
United States	Dermatology Research Associates	Los Angeles	California
United States	DS Research	Louisville	Kentucky
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Tory Sullivan, MD PA	North Miami Beach	Florida
United States	Nona Pediatrics	Orlando	Florida
United States	Accel Research - Ormond Clinical Research Unit	Ormond Beach	Florida
United States	Elite Clinical Studies, LLC	Phoenix	Arizona
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	DermAssociates, LLC	Rockville	Maryland
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Olympian Clinical Research	Saint Petersburg	Florida
United States	Shahram Jacobs, MD Inc.	Sherman Oaks	California
United States	South Bend Clinic	South Bend	Indiana
United States	Premier Clinical Research, LLC	Spokane	Washington
United States	Houston Center for Clinical Research	Sugar Land	Texas
United States	Clinical Trials Research Institute	Thousand Oaks	California
United States	Peak Research, LLC	Upper Saint Clair	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Acrotech Biopharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, Day 29
Secondary	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	Baseline, Day 15, Day 22 and Day 29