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
Organon and Co
180 participants
Dec 29, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria10
- 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
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Interventions
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.
Applied topically once daily to lesions on participant's skin during the Double-Blind period.
Locations(48)
View Full Details on ClinicalTrials.gov
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NCT07265479