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

Last updated: August 13, 2024
Sponsor: Acrotech Biopharma Inc.
Overall Status: Completed

Phase

3

Condition

Eczema (Atopic Dermatitis - Pediatric)

Allergy

Hives (Urticaria)

Treatment

Difamilast

Placebo

Clinical Study ID

NCT05608343
MM36-301
  • Ages > 2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ageof consent) provide written informed consent in accordance with federal and/or locallaws prior to the conduct of any study-related procedures.

  3. Subjects who have a diagnosis of AD based on the American Academy of Dermatology ADdiagnostic criteria

  4. Subjects who have had a diagnosis of AD for at least 6 months prior to Screeningvisit

  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 IGAof AD Severity score at screening and baseline visit

Exclusion

Important Exclusion Criteria:

  1. Female subjects who are pregnant or breastfeeding or who plan to become pregnantduring 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 andbaseline visits

  3. Subjects who have a history of unstable AD as assessed by the Investigator. UnstableAD 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, herpeszoster, and chicken pox) and/or clinically infected AD

  5. Subject with greater than mild depression and suicidal ideation prior to screeningor between screening and baseline visits

  6. Subjects who have a known history of alcohol abuse or illicit drugs within 6 monthsprior to screening

Etc.,

Study Design

Total Participants: 153
Treatment Group(s): 2
Primary Treatment: Difamilast
Phase: 3
Study Start date:
October 01, 2022
Estimated Completion Date:
October 27, 2023

Connect with a study center

  • AllerVie Health

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Elite Clinical Studies, LLC

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • NEA Baptist Clinic-Dermatology

    Jonesboro, Arkansas 72405
    United States

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Site Not Available

  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Shahram Jacobs, MD Inc.

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Clinical Trials Research Institute

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • IMMUNOe Research Centers

    Centennial, Colorado 80112
    United States

    Site Not Available

  • TrueBlue Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Accel Research - Edgewater Clinical Research Unit

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Complete Health Research

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Tory Sullivan, MD PA

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Nona Pediatrics

    Orlando, Florida 32829
    United States

    Site Not Available

  • Accel Research - Ormond Clinical Research Unit

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Complete Health Research

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Olympian Clinical Research

    Saint Petersburg, Florida 33706
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • DS Research

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • South Bend Clinic

    South Bend, Indiana 46617
    United States

    Site Not Available

  • DS Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Avant Research Associates, LLC

    Crowley, Louisiana 70526
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • DermAssociates, LLC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Oakland Hills Dermatology, PC

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Dermatology Consulting Services, PLLC

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Optima Research

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Remington-Davis, Inc.

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Peak Research, LLC

    Upper Saint Clair, Pennsylvania 15241
    United States

    Site Not Available

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Arlington Research Center, Inc.

    Arlington, Texas 76011
    United States

    Site Not Available

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Site Not Available

  • Center for Clinical Studies, Ltd, LLP

    Houston, Texas 77004
    United States

    Site Not Available

  • Houston Center for Clinical Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Premier Clinical Research, LLC

    Spokane, Washington 99202
    United States

    Site Not Available

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