RecruitingAtopic Dermatitis

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

Eligible age

0.3–1.9 yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

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About this study

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.

Sponsor: Organon and Co

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