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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 Oct 21, 2026, 8:38 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 15, 2022 (Actual)
Primary completion
Jul 31, 2024 (Actual)
Completion
Jul 31, 2024 (Actual)
Last update posted
Aug 9, 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 9, 2024 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05571943 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →