A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis
- Registration Number
- NCT05571943
- Lead Sponsor
- Acrotech Biopharma Inc.
- Brief Summary
This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 542
- Subjects who are male or female ≥2 years of age at Screening (Visit 1).
- 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 3 months prior to Screening .
- Subjects who have an IGA of mild or moderate AD Severity and treatable body surface area (BSA) ≥3%at Baseline if not previously enrolled in study MEDI-MM36-301 OR b. IGA ≤ 3, with no minimum BSA and completed through Week 4/EOT Visit 6 of the study MEDI-MM36-301.
- Subject is willing and able to comply with all study-related procedures, including, but not limited to, application of the study drug, and visit requirements.
Important
-
Subjects who have an AD flare (defined as rapid intensification of AD) within 28 days prior to Screening or Baseline (except for those previously enrolled in Study MEDI-MM36-301) or history of consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms.
-
Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD
-
Subjects with significant systemic or localized infection
-
Subjects with minimal/mild depression and suicidal ideation
-
Subjects using restricted medications, biologics and alternative therapies, or using investigational drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Difamilast Ointment 1% Difamilast A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)
- Primary Outcome Measures
Name Time Method The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug 52 week study period Proportion of subjects who discontinue due to an AE over the study period 52-week study period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Qualmedica Research, LLC
🇺🇸Bowling Green, Kentucky, United States
Antelope Valley Clinical Trials
🇺🇸Lancaster, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
AllerVie Health
🇺🇸Birmingham, Alabama, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
NEA Baptist Clinic-Dermatology
🇺🇸Jonesboro, Arkansas, United States
Southern CA Dermatology Skin and Laser
🇺🇸Laguna Niguel, California, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Clarity Dermatology, LLC
🇺🇸Castle Rock, Colorado, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
TrueBlue Clinical Research
🇺🇸Brandon, Florida, United States
Skin Care Research
🇺🇸Hollywood, Florida, United States
Accel Research - Edgewater Clinical Research Unit
🇺🇸Edgewater, Florida, United States
Kirsch Dermatology
🇺🇸Naples, Florida, United States
Accel Research - Ormond Clinical Research Unit
🇺🇸Ormond Beach, Florida, United States
Olympian Clinical Research
🇺🇸Saint Petersburg, Florida, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Meridian Clinical Research
🇺🇸Overland Park, Kansas, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Options Research Group, LLC
🇺🇸West Lafayette, Indiana, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Avant Research Associates, LLC
🇺🇸Crowley, Louisiana, United States
DermAssociates, LLC
🇺🇸Rockville, Maryland, United States
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Michigan Dermatology Institute
🇺🇸Waterford, Michigan, United States
Cleaver Dermatology
🇺🇸Kirksville, Missouri, United States
Bexley Dermatology Research
🇺🇸Bexley, Ohio, United States
Remington-Davis, Inc.
🇺🇸Columbus, Ohio, United States
Optimed Research
🇺🇸Columbus, Ohio, United States
Vivida Dermatology
🇺🇸Las Vegas, Nevada, United States
Optima Research
🇺🇸Boardman, Ohio, United States
Dermatology Associates of Plymouth Meeting
🇺🇸Plymouth Meeting, Pennsylvania, United States
Peak Research, LLC
🇺🇸Upper Saint Clair, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Anderson, South Carolina, United States
International Clinical Research - Tennessee, LLC
🇺🇸Murfreesboro, Tennessee, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Center for Clinical Studies, Ltd, LLP
🇺🇸Houston, Texas, United States
J&S Studies
🇺🇸College Station, Texas, United States
North Texas Center for Clinical Research
🇺🇸Frisco, Texas, United States
Premier Clinical Research, LLC
🇺🇸Spokane, Washington, United States
Houston Center for Clinical Research
🇺🇸Sugar Land, Texas, United States
Research Your Health
🇺🇸Plano, Texas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Clinical Trials Research Institute
🇺🇸Thousand Oaks, California, United States
Tory Sullivan, MD PA
🇺🇸North Miami Beach, Florida, United States
Forest Hills Dermatology Group
🇺🇸Kew Gardens, New York, United States
Oakland Hills Dermatology, PC
🇺🇸Auburn Hills, Michigan, United States
Pure Skin Dermatology & Aesthetics
🇺🇸Orlando, Florida, United States
Nona Pediatrics
🇺🇸Orlando, Florida, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Derm Research
🇺🇸Austin, Texas, United States
Annexus Dermatology & Aethestics
🇺🇸DeLand, Florida, United States