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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT07265479

Run by

Organon and Co

People needed

180

Starts

2025-12-29

Expected to finish

2028-01-01

Last updated by the study team

2026-07-16

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AllerVie Clinical Research — Birmingham, Alabama, United States (enrolling)
• Dermatology Trial Associates — Bryant, Arkansas, United States (enrolling)
• Dermatology Research Associates — Los Angeles, California, United States (enrolling)
• Integrative Skin Science and Research — Sacramento, California, United States (enrolling)
• Allergy and Asthma Medical Group and Research Center — San Diego, California, United States (enrolling)
• Clinical Trials Research Institute — Thousand Oaks, California, United States (enrolling)
• Clarity Dermatology — Castle Rock, Colorado, United States (enrolling)
• Skin Care Research, LLC. — Boca Raton, Florida, United States (enrolling)
• APEX Clinical Trials — Jacksonville, Florida, United States (enrolling)
• TruDerm Research — Wellington, Florida, United States (enrolling)
• Cleaver Medical Group Dermatology, Inc — Cumming, Georgia, United States (enrolling)
• Ada West Research — Meridian, Idaho, United States (enrolling)
• Endeavor Health Clinical Trials Center — Skokie, Illinois, United States (enrolling)
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (enrolling)
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States (enrolling)
• Equity Medical, LLC — Bowling Green, Kentucky, United States (enrolling)
• Lawrence J Green, MD LLC — Rockville, Maryland, United States (enrolling)
• Oakland Hills Dermatology — Auburn Hills, Michigan, United States (enrolling)
• Minnesota Clinical Study Center — New Brighton, Minnesota, United States (enrolling)
• SKY Integrative Medical Center — Ridgeland, Mississippi, United States (enrolling)
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States (enrolling)
• Skin Cancer and Dermatology Institute — Reno, Nevada, United States (enrolling)
• Forest Hills Dermatology Group — Kew Gardens, New York, United States (enrolling)
• Bobby Buka MD, PC — New York, New York, United States (enrolling)
• Equity Medical, LLC — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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