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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 Oct 16, 2026, 6:54 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
Oct 1, 2022 (Actual)
Primary completion
Oct 27, 2023 (Actual)
Completion
Oct 27, 2023 (Actual)
Last update posted
Aug 15, 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 15, 2024 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05608343 live on ClinicalTrials.gov.

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