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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT07265479•Organon and Co

View on ClinicalTrials.gov

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

Age

0 - 1 years

Sex

ALL

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

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

Key Dates

Start Date

December 29, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

March 13, 2026

Enrollment

180

ESTIMATED participants

Conditions

Atopic Dermatitis

Interventions

Tapinarof cream, 1%

DRUG

Vehicle Cream

DRUG

Contacts

Clinical Lead Late-Stage Clinical Development

CONTACT

551-430-6000 studysites@organon.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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