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NCT07265479PHASE3Recruiting

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

Organon and Co

Start Date

12/29/2025

Completion Date

1/1/2028

Summary

The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \<24 months of age at the Screening visit. * Clinical diagnosis of atopic dermatitis (AD), AD covering \>5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4 * Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities * Legal guardian or primary caregiver is able and willing to adhere to protocol requirements Exclusion Criteria: * Significant neurological disorder or history of seizure * Know clinically significant cardiac rhythm or cardiac disorder * History of sudden infant death in a sibling * Clinically significant chromosome abnormality * History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation * Diseases that could cause pruritic and/or sleep disruption * Immunocompromised * Current chronic or acute infection requiring treatment * Use of prohibited medication(s) or procedure(s) * Use of prohibited medications by breastfeeding mother if breastfeeding participant

Interventions

DRUG

Tapinarof cream, 1%

DRUG

Vehicle Cream

Interested in This Trial?

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Conditions

Atopic Dermatitis

Locations

AllerVie Clinical Research

Birmingham, Alabama 35209

United States

Dermatology Trial Associates

Bryant, Arkansas 72022

United States

Dermatology Research Associates

Los Angeles, California 90045

United States

Integrative Skin Science and Research

Sacramento, California 95815

United States

Allergy and Asthma Medical Group and Research Center

San Diego, California 92123

United States

Clinical Trials Research Institute

Thousand Oaks, California 91320

United States

Clarity Dermatology

Castle Rock, Colorado 80109

United States

Skin Care Research, LLC.

Boca Raton, Florida 33486

United States

APEX Clinical Trials

Jacksonville, Florida 32256

United States

TruDerm Research

Wellington, Florida 33449

United States

Cleaver Medical Group Dermatology, Inc

Cumming, Georgia 30040

United States

Ada West Research

Meridian, Idaho 83646

United States

Endeavor Health Clinical Trials Center

Skokie, Illinois 60077

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana 46168

United States

Equity Medical, LLC

Bowling Green, Kentucky 42104

United States

Lawrence J Green, MD LLC

Rockville, Maryland 20850

United States

Oakland Hills Dermatology

Auburn Hills, Michigan 48326

United States

Minnesota Clinical Study Center

New Brighton, Minnesota 55112

United States

SKY Integrative Medical Center

Ridgeland, Mississippi 39157

United States

MediSearch Clinical Trials

Saint Joseph, Missouri 64506

United States

Skin Cancer and Dermatology Institute

Reno, Nevada 89509

United States

Forest Hills Dermatology Group

Kew Gardens, New York 11415

United States

Bobby Buka MD, PC

New York, New York 10012

United States

Equity Medical, LLC

The Bronx, New York 10455

United States

The University of North Carolina Dermatology and Skin Cancer Center

Chapel Hill, North Carolina 27516

United States

Dermatologists of Central States, LLC

Fairborn, Ohio 45324

United States

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma 73120

United States

Oregon Dermatology and Research Center

Portland, Oregon 97210

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina 29420

United States

The University of Texas Health Science Center at Houston

Bellaire, Texas 77401

United States

Dermatology Treatment and Research Center

Dallas, Texas 75230

United States

Stryde Research - Epiphany Dermatology

Southlake, Texas 76092

United States

Dermatology Specialists of Spokane

Spokane, Washington 99202

United States

Dermatology Research Institute

Calgary, Alberta T2J 7E1

Canada

CARe Clinic (Central Alberta Research Clinic)

Red Deer, Alberta T4P 1K4

Canada

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia V3R 6A7

Canada

Manitoba Allergy Research Inc.

Winnipeg, Manitoba R3J 0S9

Canada

Maritime Dermatology

Halifax, Nova Scotia B3K 5R3

Canada

Halton Pediatric Allergy

Burlington, Ontario L7L 6W6

Canada

Triple A Lab Inc.

Hamilton, Ontario L8S 1G5

Canada

Allergy Research Canada Inc.

Niagara Falls, Ontario L2H 1C4

Canada

Dr. Rachel Asiniwasis Medical Professional Corporation

Regina, Saskatchewan S4V 1R9

Canada

Skinsense Medical Research

Saskatoon, Saskatchewan S7K 2C1

Canada