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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05608343

Public ClinicalTrials.gov record NCT05608343. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05608343
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Acrotech Biopharma Inc.
Industry
Enrollment
153 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2022
Primary completion
Oct 26, 2023
Completion
Oct 26, 2023
Last update posted
Aug 14, 2024

2022 – 2023

United States locations

U.S. sites
39
U.S. states
20
U.S. cities
39
Facility City State ZIP Site status
AllerVie Health Birmingham Alabama 35244
Elite Clinical Studies, LLC Phoenix Arizona 85018
NEA Baptist Clinic-Dermatology Jonesboro Arkansas 72405
First OC Dermatology Fountain Valley California 92708
Center for Dermatology Clinical Research, Inc. Fremont California 94538
Antelope Valley Clinical Trials Lancaster California 93534
Dermatology Research Associates Los Angeles California 90045
Shahram Jacobs, MD Inc. Sherman Oaks California 91403
Clinical Trials Research Institute Thousand Oaks California 91320
IMMUNOe Research Centers Centennial Colorado 80112
TrueBlue Clinical Research Brandon Florida 33511
Accel Research - Edgewater Clinical Research Unit Edgewater Florida 32132
Tory Sullivan, MD PA North Miami Beach Florida 33162
Nona Pediatrics Orlando Florida 32829
Accel Research - Ormond Clinical Research Unit Ormond Beach Florida 32174
Olympian Clinical Research St. Petersburg Florida 33706
Arlington Dermatology Rolling Meadows Illinois 60008
DS Research Clarksville Indiana 47129
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana 46250
The Indiana Clinical Trials Center Plainfield Indiana 46168
South Bend Clinic South Bend Indiana 46617
DS Research Louisville Kentucky 40241
Avant Research Associates, LLC Crowley Louisiana 70526
Clinical Trials Management, LLC Metairie Louisiana 70006
DermAssociates, LLC Rockville Maryland 20850
Metro Boston Clinical Partners Brighton Massachusetts 02135
Oakland Hills Dermatology, PC Auburn Hills Michigan 48326
Minnesota Clinical Study Center New Brighton Minnesota 55112
Dermatology Consulting Services, PLLC High Point North Carolina 27262
Bexley Dermatology Research Bexley Ohio 43209
Optima Research Boardman Ohio 44512
Remington-Davis, Inc. Columbus Ohio 43215
Peak Research, LLC Upper Saint Clair Pennsylvania 15241
International Clinical Research - Tennessee LLC Murfreesboro Tennessee 37130
Arlington Research Center, Inc. Arlington Texas 76011
North Texas Center for Clinical Research Frisco Texas 75034
Center for Clinical Studies, Ltd, LLP Houston Texas 77004
Houston Center for Clinical Research Sugar Land Texas 77479
Premier Clinical Research, LLC Spokane Washington 99202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05608343, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 14, 2024 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05608343 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →