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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05608343
Recruitment Status : Recruiting
First Posted : November 8, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Acrotech Biopharma Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Difamilast Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Difamilast Ointment 1% in Children, Adolescents, and Adults With Mild to Moderate Atopic Dermatitis
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Difamilast Ointment
1% Difamilast Ointment
 Drug: Difamilast
Off-white ointment containing active ingredient, petrolatum and other ingredients
Placebo Comparator: Vehicle Controlled
Matching placebo
 Drug: Placebo
Matching Difamilast (Study drug) ointment without active ingradient


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Important Exclusion Criteria:

  1. 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
  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.,

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05608343


Contacts
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Contact: Stephanie Magajna, MS 208-719-7876 smagajna@therapeuticsinc.com

Locations
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Sponsors and Collaborators
Acrotech Biopharma Inc.
Investigators
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Study Director: Uma Srinivas Atmuri, MPharm MS Acrotech Biopharma Inc.
More Information
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Responsible Party: Acrotech Biopharma Inc.
ClinicalTrials.gov Identifier: NCT05608343    
Other Study ID Numbers: MM36-301
First Posted: November 8, 2022    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases