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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07265479). StuddyBuddy aggregates publicly available trial information.