This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
NCT ID: NCT05608343
Last Updated: 2024-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
153 participants
INTERVENTIONAL
2022-10-01
2023-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Difamilast Ointment
1% Difamilast Ointment
Difamilast
Off-white ointment containing active ingredient, petrolatum and other ingredients
Vehicle Controlled
Matching placebo
Placebo
Matching Difamilast (Study drug) ointment without active ingradient
Interventions
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Difamilast
Off-white ointment containing active ingredient, petrolatum and other ingredients
Placebo
Matching Difamilast (Study drug) ointment without active ingradient
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.,
2 Years
ALL
No
Sponsors
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Acrotech Biopharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Uma Srinivas Atmuri, MPharm MS
Role: STUDY_DIRECTOR
Acrotech Biopharma Inc.
Locations
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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
TrueBlue Clinical Research
Brandon, Florida, United States
Accel Research - Edgewater Clinical Research Unit
Edgewater, Florida, 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
Olympian Clinical Research
St. Petersburg, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
DS Research
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
DS Research
Louisville, Kentucky, United States
Avant Research Associates, LLC
Crowley, Louisiana, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
DermAssociates, LLC
Rockville, Maryland, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
Oakland Hills Dermatology, PC
Auburn Hills, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Optima Research
Boardman, Ohio, United States
Remington-Davis, Inc.
Columbus, Ohio, United States
Peak Research, LLC
Upper Saint Clair, Pennsylvania, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
Center for Clinical Studies, Ltd, LLP
Houston, Texas, United States
Houston Center for Clinical Research
Sugar Land, Texas, United States
Premier Clinical Research, LLC
Spokane, Washington, United States
Countries
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Other Identifiers
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MM36-301
Identifier Type: -
Identifier Source: org_study_id
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