A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Organon and Co
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
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Significant neurologic…
Interventions
- DrugTapinarof cream, 1%
Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.
- DrugVehicle Cream
Applied topically once daily to lesions on participant's skin during the Double-Blind period.
Locations (48)
- AllerVie Clinical ResearchBirmingham, Alabama
- Dermatology Trial AssociatesBryant, Arkansas
- Dermatology Research AssociatesLos Angeles, California
- Integrative Skin Science and ResearchSacramento, California
- Allergy and Asthma Medical Group and Research CenterSan Diego, California
- Clinical Trials Research InstituteThousand Oaks, California