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Completed

NCT Number: NCT05608343

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AllerVie Health, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Important Inclusion Criteria:

  • Subjects who are male or female ≥2 years of age
  • 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.
  • 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 6 months prior to Screening visit
  • Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
  • 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:

  • 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
  • Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
  • 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
  • Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD
  • Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
  • Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening

Etc.,

Treatment and study plan

Difamilast

Drug

Off-white ointment containing active ingredient, petrolatum and other ingredients

Placebo

Drug

Matching Difamilast (Study drug) ointment without active ingradient

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Acrotech Biopharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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