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

NCT07265479 · tracked via the Priya Life Science USA tracker

Sponsor

Organon and Co

Phase

Phase 3

Started

2025-12-29

Last updated

2026-08-12

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Tapinarof cream, 1%Vehicle Cream

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.

Study 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

Sex

ALL

Min age

3 Months

Max age

23 Months

Healthy volunteers

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

Primary outcome measure(s)

Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8 — Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.
Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period — Baseline to the end of the Open-Label Period, up to 56 weeks.
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint.. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.

Trial sites (46)

Facility	City	Region
AllerVie Clinical Research	Birmingham	Alabama
Dermatology Trial Associates	Bryant	Arkansas
Dermatology Research Associates	Los Angeles	California
Integrative Skin Science and Research	Sacramento	California
Allergy and Asthma Medical Group and Research Center	San Diego	California
Clinical Trials Research Institute	Thousand Oaks	California
Clarity Dermatology	Castle Rock	Colorado
Skin Care Research, LLC.	Boca Raton	Florida
APEX Clinical Trials	Jacksonville	Florida
TruDerm Research	Wellington	Florida
Cleaver Medical Group Dermatology, Inc	Cumming	Georgia
Ada West Research	Meridian	Idaho
Endeavor Health Clinical Trials Center	Skokie	Illinois
Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
The Indiana Clinical Trials Center, PC	Plainfield	Indiana
Equity Medical, LLC	Bowling Green	Kentucky
Lawrence J Green, MD LLC	Rockville	Maryland
Oakland Hills Dermatology	Auburn Hills	Michigan
Minnesota Clinical Study Center	New Brighton	Minnesota
SKY Integrative Medical Center	Ridgeland	Mississippi
MediSearch Clinical Trials	Saint Joseph	Missouri
Skin Cancer and Dermatology Institute	Reno	Nevada
Forest Hills Dermatology Group	Kew Gardens	New York
Bobby Buka MD, PC	New York	New York
Equity Medical, LLC	The Bronx	New York
The University of North Carolina Dermatology and Skin Cancer Center	Chapel Hill	North Carolina
Dermatologists of Central States, LLC	Fairborn	Ohio
Allergy Asthma and Clinical Research Center	Oklahoma City	Oklahoma
Oregon Dermatology and Research Center	Portland	Oregon
Oregon Health & Science University	Portland	Oregon
Medical University of South Carolina	Charleston	South Carolina
National Allergy and Asthma Research, LLC.	North Charleston	South Carolina
The University of Texas Health Science Center at Houston	Bellaire	Texas
Dermatology Treatment and Research Center	Dallas	Texas
Stryde Research - Epiphany Dermatology	Southlake	Texas
Dermatology Specialists of Spokane	Spokane	Washington
Dermatology Research Institute	Calgary	Alberta
CARe Clinic (Central Alberta Research Clinic)	Red Deer	Alberta
Dr. Chih-Ho Hong Medical Inc.	Surrey	British Columbia
Manitoba Allergy Research Inc.	Winnipeg	Manitoba

+ 6 more sites — see the full list on the official registry below.

More Organon and Co trials in the USA

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects Active, not recruiting

Other trials for the same condition

ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis Active, not recruiting

10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus Active, not recruiting

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis Active, not recruiting

A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis Recruiting

A Clinical Trial to Evaluate the Effects of Rejuvaskin Eczema Body Wash and Skin Recovery Cream in Adults With Eczema-Prone Skin Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265479 on ClinicalTrials.gov ↗ ← All trials in the USA