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Study details
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A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

Organon and Co
NCT IDNCT07265479ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

180

Study length

about 2.1 years

Ages

0.25–1.91666666666667

Locations

38 sites in AL, AR, CA +21

What this study is about

Researchers are testing the safety and effectiveness of tapinarof cream, a topical treatment, for children aged 3 months to under 2 years with atopic dermatitis. The trial will last approximately 761 days.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Tapinarof cream, 1%
  • 2.Take Vehicle Cream

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
topicaltopical

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

DERMATOLOGICALS

Drug routes

topical

Endpoints

Secondary: Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall), Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas), Number of participants with one or more Treatment Emergent Adverse Events (TEAEs), Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)

Body systems

Dermatology