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

Eligibility Criteria

Sex

ALL

Age

3 Months - 23 Months

Healthy Volunteers

Not accepted

Interventions

• Tapinarof cream, 1% — DRUG
  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.
• Vehicle Cream — DRUG
  Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Study Details

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.

Key Dates

Start date

Dec 29, 2025

Status verified

Feb 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8 [ Time Frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. ]

Central Contacts

• Clinical Lead Late-Stage Clinical Development
  551-430-6000
  [email protected]

Locations (37)

Find similar trials in Birmingham, AL

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