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Completed Phase 3 Interventional

A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

ClinicalTrials.gov ID: NCT05571943

Public ClinicalTrials.gov record NCT05571943. 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 2, 2026, 1:44 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 Multicenter, Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in the Treatment of 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, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

Study identification

NCT ID
NCT05571943
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Acrotech Biopharma Inc.
Industry
Enrollment
542 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 14, 2022
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Last update posted
Aug 8, 2024

2022 – 2024

United States locations

U.S. sites
63
U.S. states
26
U.S. cities
60
Facility City State ZIP Site status
Qualmedica Research, LLC Birmingham Alabama 35205
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
Southern CA Dermatology Skin and Laser Laguna Niguel California 92677
Antelope Valley Clinical Trials Lancaster California 93534
Dermatology Research Associates Los Angeles California 90045
Clinical Trials Research Institute Thousand Oaks California 91320
Clarity Dermatology, LLC Castle Rock Colorado 80109
IMMUNOe Research Centers Centennial Colorado 80112
TrueBlue Clinical Research Brandon Florida 33511
Annexus Dermatology & Aethestics DeLand Florida 32720
Accel Research - Edgewater Clinical Research Unit Edgewater Florida 32132
Skin Care Research Hollywood Florida 33021
Kirsch Dermatology Naples Florida 34102
Tory Sullivan, MD PA North Miami Beach Florida 33162
Pure Skin Dermatology & Aesthetics Orlando Florida 32819
Nona Pediatrics Orlando Florida 32829
Accel Research - Ormond Clinical Research Unit Ormond Beach Florida 32174
Olympian Clinical Research St. Petersburg Florida 33706
Solaris Clinical Research Meridian Idaho 83646
Arlington Dermatology Rolling Meadows Illinois 60008
DS Research Clarksville Indiana 47129
Qualmedica Research, LLC Evansville Indiana 47715
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana 46250
The Indiana Clinical Trials Center Plainfield Indiana 46168
South Bend Clinic South Bend Indiana 46617
Options Research Group, LLC West Lafayette Indiana 47906
Meridian Clinical Research Overland Park Kansas 66210
Qualmedica Research, LLC Bowling Green Kentucky 42101
DS Research Louisville Kentucky 40241
Clinical Trials Management, LLC Covington Louisiana 70433
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
Michigan Dermatology Institute Waterford Michigan 48328
Minnesota Clinical Study Center New Brighton Minnesota 55112
Cleaver Dermatology Kirksville Missouri 63501
Vivida Dermatology Las Vegas Nevada 89119
Forest Hills Dermatology Group Kew Gardens New York 11415
Bexley Dermatology Research Bexley Ohio 43209
Optima Research Boardman Ohio 44512
Remington-Davis, Inc. Columbus Ohio 43215
Optimed Research Columbus Ohio 43235
Oregon Health and Science University Portland Oregon 97239
Dermatology Associates of Plymouth Meeting Plymouth Meeting Pennsylvania 19462
Peak Research, LLC Upper Saint Clair Pennsylvania 15241
Palmetto Clinical Trial Services, LLC Anderson South Carolina 29621
Coastal Pediatric Research Charleston South Carolina 29414
International Clinical Research - Tennessee, LLC Murfreesboro Tennessee 37130
Arlington Research Center, Inc. Arlington Texas 76011
Derm Research Austin Texas 78759
J&S Studies College Station Texas 77845
North Texas Center for Clinical Research Frisco Texas 75034
Center for Clinical Studies, Ltd, LLP Houston Texas 77004
Research Your Health Plano Texas 75093
Houston Center for Clinical Research Sugar Land Texas 77479
Center for Clinical Studies Webster Texas 77598
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 NCT05571943, 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 8, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05571943 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →