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

NCT05608343 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2024-08-15

No results posted yet for this 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.

Conditions

Interventions

DRUG

Difamilast

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

DRUG

Placebo

Matching Difamilast (Study drug) ointment without active ingradient

Sponsors & Collaborators

  • Acrotech Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Uma Srinivas Atmuri, MPharm MS · Acrotech Biopharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-10-27
Completion
2023-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608343 on ClinicalTrials.gov