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NCT07265479
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Conditions: Atopic Dermatitis
Sex: All
Ages: 3 Months – 23 Months
Healthy volunteers: No
Phase: PHASE3
Enrollment: 180
Sponsor: Organon and Co
Location: AllerVie Clinical Research Birmingham Alabama
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 Criteria
Inclusion Criteria:
* Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to \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
* 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
Source: ClinicalTrials.gov (NCT07265479). StuddyBuddy aggregates publicly available trial information.