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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Tapinarof cream, 1%
  • 2.Take Vehicle Cream
PhasePhase 3
DrugTapinarof cream, 1%
Routetopical

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low7%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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