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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• 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

+ 35 more sites.

Who to contact

Clinical Lead Late-Stage Clinical Development · 551-430-6000 · studysites@organon.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07265479.