A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
Purpose
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.
Condition
- Atopic Dermatitis
Eligibility
- Eligible Ages
- Between 3 Months and 23 Months
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Following a screening period of up to 30 days, eligible participants will be randomly assigned to one of two groups for up to 8 weeks. During this time-called the Double-Blind Period-2 out of 3 participants will receive the active treatment (tapinarof cream, 1%), while 1 out of 3 will receive a vehicle cream (placebo). Following completion of the Double-blind period, participants will enter the 48-week Open Label Period and will be treated as needed.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tapinarof cream |
Tapinarof cream, 1%, applied topically once daily |
|
|
Placebo Comparator Vehicle cream |
Vehicle cream is applied topically once daily for up to 8-weeks. |
|
Recruiting Locations
The University of Texas Health Science Center at Houston
Bellaire, Texas 77401
Bellaire, Texas 77401
More Details
- Status
- Recruiting
- Sponsor
- Organon and Co