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.
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
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
Organon and Co
Lead sponsor