Overview
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 Criteria:
- Infants and toddlers 3 months to \<24 months (post-natal) 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
- Clinically significant cardiac rhythm or functional 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 mother if breastfeeding participant