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A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Sponsor: Organon and Co
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.
Official title: A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Key Details
Gender
All
Age Range
3 Months - 23 Months
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-12-29
Completion Date
2028-01
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Tapinarof cream, 1%
Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.
Vehicle Cream
Applied topically once daily to lesions on participant's skin during the Double-Blind period.
Locations (48)
AllerVie Clinical Research
Birmingham, Alabama, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
Clarity Dermatology
Castle Rock, Colorado, United States
Skin Care Research, LLC.
Boca Raton, Florida, United States
APEX Clinical Trials
Jacksonville, Florida, United States
TruDerm Research
Wellington, Florida, United States
Cleaver Medical Group Dermatology, Inc
Cumming, Georgia, United States
Ada West Research
Meridian, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Equity Medical, LLC
Bowling Green, Kentucky, United States
Lawrence J Green, MD LLC
Rockville, Maryland, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
SKY Integrative Medical Center
Ridgeland, Mississippi, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Bobby Buka MD, PC
New York, New York, United States
Equity Medical, LLC
The Bronx, New York, United States
The University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Dermatologists of Central States, LLC
Fairborn, Ohio, United States
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
National Allergy and Asthma Research, LLC.
North Charleston, South Carolina, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Stryde Research - Epiphany Dermatology
Southlake, Texas, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Dermatology Research Institute
Calgary, Alberta, Canada
CARe Clinic (Central Alberta Research Clinic)
Red Deer, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Manitoba Allergy Research Inc.
Winnipeg, Manitoba, Canada
Maritime Dermatology
Halifax, Nova Scotia, Canada
Halton Pediatric Allergy
Burlington, Ontario, Canada
Triple A Lab Inc.
Hamilton, Ontario, Canada
Allergy Research Canada Inc.
Niagara Falls, Ontario, Canada
Dr. Rachel Asiniwasis Medical Professional Corporation
Regina, Saskatchewan, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada