Actively Recruiting
A Randomized, Double-Blind, Vehicle-Controlled and Open-Label Phase 3 Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Children Ages 3 Months to Less Than 24 Months with Atopic Dermatitis
Led by Organon and Co · Updated on 2026-06-04
180
Participants Needed
47
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tapinarof cream, 1%, in young children aged 3 months to less than 24 months who have atopic dermatitis, a skin condition. This global Phase 3 clinical study aims to better understand how well the cream works and how safe it is for this very young age group. Participants will be randomly assigned to apply either tapinarof cream or a vehicle cream (a placebo) once daily to affected skin areas for up to 8 weeks during a double-blind period. After this phase, all participants may use tapinarof cream once daily as needed during an open-label period lasting up to 56 weeks. The study compares the effects of tapinarof cream against the vehicle cream and monitors participants over time. Throughout the study, caregivers and researchers will assess skin improvement using the Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and the Eczema Area and Severity Index (EASI). Safety will be closely monitored by recording any treatment-related side effects and local skin reactions. The trial includes regular visits and evaluations over the initial 8-week double-blind phase and continued monitoring during the longer open-label phase, which can last up to 56 weeks in total.
CONDITIONS
Brief Title
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants and toddlers born at term (37 weeks of gestational age or more) aged 3 months to less than 24 months at Screening
- Clinical diagnosis of atopic dermatitis covering more than 5% Body Surface Area
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3, or 4
- Legal guardian or primary caregiver able and willing to sign informed consent and follow study requirements
You will not qualify if you...
- History of significant neurological disorder or seizures
- Known clinically significant cardiac rhythm or cardiac disorder
- History of sudden infant death in a sibling
- Clinically significant chromosome abnormalities
- Serious illness or medical, physical, or psychiatric conditions interfering with participation
- Diseases causing itching or sleep disruption
- Immunocompromised status
- Current chronic or acute infection requiring treatment
- Use of prohibited medications or procedures
- Use of prohibited medications by breastfeeding mother if participant is breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants apply Tapinarof cream, 1% or Vehicle cream topically once daily to skin lesions during the Double-Blind Period.
Weekly visits for up to 8 weeks
Duration - Up to 48 weeks
Participants apply Tapinarof cream, 1% once daily as needed during the Open-Label Period.
Regular visits during the Open-Label Period
Trial Site Locations
Total: 47 locations
1
AllerVie Clinical Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Dermatology Trial Associates
Bryant, Arkansas, United States, 72022
Actively Recruiting
3
Dermatology Research Associates
Los Angeles, California, United States, 90045
Actively Recruiting
4
Integrative Skin Science and Research
Sacramento, California, United States, 95815
Actively Recruiting
5
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States, 92123
Actively Recruiting
6
Clinical Trials Research Institute
Thousand Oaks, California, United States, 91320
Actively Recruiting
7
Clarity Dermatology
Castle Rock, Colorado, United States, 80109
Actively Recruiting
8
Skin Care Research, LLC.
Boca Raton, Florida, United States, 33486
Actively Recruiting
9
APEX Clinical Trials
Jacksonville, Florida, United States, 32256
Actively Recruiting
10
TruDerm Research
Wellington, Florida, United States, 33449
Actively Recruiting
11
Cleaver Medical Group Dermatology, Inc
Cumming, Georgia, United States, 30040
Actively Recruiting
12
Ada West Research
Meridian, Idaho, United States, 83646
Actively Recruiting
13
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States, 60077
Actively Recruiting
14
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Actively Recruiting
15
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
Actively Recruiting
16
Equity Medical, LLC
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
17
Lawrence J Green, MD LLC
Rockville, Maryland, United States, 20850
Actively Recruiting
18
Oakland Hills Dermatology
Auburn Hills, Michigan, United States, 48326
Actively Recruiting
19
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
Actively Recruiting
20
SKY Integrative Medical Center
Ridgeland, Mississippi, United States, 39157
Actively Recruiting
21
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
22
Skin Cancer and Dermatology Institute
Reno, Nevada, United States, 89509
Actively Recruiting
23
Forest Hills Dermatology Group
Kew Gardens, New York, United States, 11415
Actively Recruiting
24
Bobby Buka MD, PC
New York, New York, United States, 10012
Actively Recruiting
25
Equity Medical, LLC
The Bronx, New York, United States, 10455
Actively Recruiting
26
The University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
27
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
28
Dermatologists of Central States, LLC
Fairborn, Ohio, United States, 45324
Actively Recruiting
29
Allergy Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
30
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Actively Recruiting
31
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
32
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
33
National Allergy and Asthma Research, LLC.
North Charleston, South Carolina, United States, 29420
Actively Recruiting
34
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States, 77401
Actively Recruiting
35
Dermatology Treatment and Research Center
Dallas, Texas, United States, 75230
Actively Recruiting
36
Stryde Research - Epiphany Dermatology
Southlake, Texas, United States, 76092
Actively Recruiting
37
Dermatology Specialists of Spokane
Spokane, Washington, United States, 99202
Actively Recruiting
38
Dermatology Research Institute
Calgary, Alberta, Canada, T2J 7E1
Actively Recruiting
39
CARe Clinic (Central Alberta Research Clinic)
Red Deer, Alberta, Canada, T4P 1K4
Actively Recruiting
40
Dr. Chih-Ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
Actively Recruiting
41
Manitoba Allergy Research Inc.
Winnipeg, Manitoba, Canada, R3J 0S9
Actively Recruiting
42
Maritime Dermatology
Halifax, Nova Scotia, Canada, B3K 5R3
Actively Recruiting
43
Halton Pediatric Allergy
Burlington, Ontario, Canada, L7L 6W6
Actively Recruiting
44
Triple A Lab Inc.
Hamilton, Ontario, Canada, L8S 1G5
Actively Recruiting
45
Allergy Research Canada Inc.
Niagara Falls, Ontario, Canada, L2H 1C4
Actively Recruiting
46
Dr. Rachel Asiniwasis Medical Professional Corporation
Regina, Saskatchewan, Canada, S4V 1R9
Actively Recruiting
47
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada, S7K 2C1
Actively Recruiting
Research Team
C
Clinical Lead Late-Stage Clinical Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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