This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- Subjects who are male or female ≥2 years of age
- 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.
- Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
- Subjects who have had a diagnosis of AD for at least 6 months prior to Screening visit
- Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
- 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
- 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
- Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
- 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
- Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD
- Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
- 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)
Nona Pediatrics
🇺🇸Orlando, Florida, United States
Tory Sullivan, MD PA
🇺🇸North Miami Beach, Florida, United States
Avant Research Associates, LLC
🇺🇸Crowley, Louisiana, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Accel Research - Edgewater Clinical Research Unit
🇺🇸Edgewater, Florida, United States
Clinical Trials Research Institute
🇺🇸Thousand Oaks, California, United States
NEA Baptist Clinic-Dermatology
🇺🇸Jonesboro, Arkansas, United States
Accel Research - Ormond Clinical Research Unit
🇺🇸Ormond Beach, Florida, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
DermAssociates, LLC
🇺🇸Rockville, Maryland, United States
Oakland Hills Dermatology, PC
🇺🇸Auburn Hills, Michigan, United States
Shahram Jacobs, MD Inc.
🇺🇸Sherman Oaks, California, United States
Olympian Clinical Research
🇺🇸Saint Petersburg, Florida, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Dermatology Consulting Services, PLLC
🇺🇸High Point, North Carolina, United States
Bexley Dermatology Research
🇺🇸Bexley, Ohio, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Antelope Valley Clinical Trials
🇺🇸Lancaster, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Remington-Davis, Inc.
🇺🇸Columbus, Ohio, United States
Center for Clinical Studies, Ltd, LLP
🇺🇸Houston, Texas, United States
AllerVie Health
🇺🇸Birmingham, Alabama, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Optima Research
🇺🇸Boardman, Ohio, United States
TrueBlue Clinical Research
🇺🇸Brandon, Florida, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
International Clinical Research - Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
Peak Research, LLC
🇺🇸Upper Saint Clair, Pennsylvania, United States
Premier Clinical Research, LLC
🇺🇸Spokane, Washington, United States
North Texas Center for Clinical Research
🇺🇸Frisco, Texas, United States
Houston Center for Clinical Research
🇺🇸Sugar Land, Texas, United States