A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis
A Multicenter, Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in the Treatment of Children, Adolescents and Adults With Mild to Moderate Atopic Dermatitis
1 other identifier
interventional
542
1 country
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2022
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2022
CompletedFirst Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedAugust 9, 2024
August 1, 2024
1.9 years
October 5, 2022
August 8, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Difamilast Ointment 1%
EXPERIMENTALA thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Qualmedica Research, LLC
Birmingham, Alabama, 35205, United States
AllerVie Health
Birmingham, Alabama, 35244, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
NEA Baptist Clinic-Dermatology
Jonesboro, Arkansas, 72405, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Southern CA Dermatology Skin and Laser
Laguna Niguel, California, 92677, United States
Antelope Valley Clinical Trials
Lancaster, California, 93534, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Clinical Trials Research Institute
Thousand Oaks, California, 91320, United States
Clarity Dermatology, LLC
Castle Rock, Colorado, 80109, United States
IMMUNOe Research Centers
Centennial, Colorado, 80112, United States
TrueBlue Clinical Research
Brandon, Florida, 33511, United States
Annexus Dermatology & Aethestics
DeLand, Florida, 32720, United States
Accel Research - Edgewater Clinical Research Unit
Edgewater, Florida, 32132, United States
Skin Care Research
Hollywood, Florida, 33021, United States
Kirsch Dermatology
Naples, Florida, 34102, United States
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162, United States
Pure Skin Dermatology & Aesthetics
Orlando, Florida, 32819, United States
Nona Pediatrics
Orlando, Florida, 32829, United States
Accel Research - Ormond Clinical Research Unit
Ormond Beach, Florida, 32174, United States
Olympian Clinical Research
St. Petersburg, Florida, 33706, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
DS Research
Clarksville, Indiana, 47129, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Options Research Group, LLC
West Lafayette, Indiana, 47906, United States
Meridian Clinical Research
Overland Park, Kansas, 66210, United States
Qualmedica Research, LLC
Bowling Green, Kentucky, 42101, United States
DS Research
Louisville, Kentucky, 40241, United States
Clinical Trials Management, LLC
Covington, Louisiana, 70433, United States
Avant Research Associates, LLC
Crowley, Louisiana, 70526, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
DermAssociates, LLC
Rockville, Maryland, 20850, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135, United States
Oakland Hills Dermatology, PC
Auburn Hills, Michigan, 48326, United States
Michigan Dermatology Institute
Waterford, Michigan, 48328, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112, United States
Cleaver Dermatology
Kirksville, Missouri, 63501, United States
Vivida Dermatology
Las Vegas, Nevada, 89119, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
Optima Research
Boardman, Ohio, 44512, United States
Remington-Davis, Inc.
Columbus, Ohio, 43215, United States
Optimed Research
Columbus, Ohio, 43235, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462, United States
Peak Research, LLC
Upper Saint Clair, Pennsylvania, 15241, United States
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, 29621, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
International Clinical Research - Tennessee, LLC
Murfreesboro, Tennessee, 37130, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Derm Research
Austin, Texas, 78759, United States
J&S Studies
College Station, Texas, 77845, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
Center for Clinical Studies, Ltd, LLP
Houston, Texas, 77004, United States
Research Your Health
Plano, Texas, 75093, United States
Houston Center for Clinical Research
Sugar Land, Texas, 77479, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Premier Clinical Research, LLC
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Uma S Atmuri, MPharm MS
Acrotech Biopharma Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 7, 2022
Study Start
September 15, 2022
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share