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Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

NCT05014568 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2025-09-04

Study results available
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Summary

This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.

Conditions

Interventions

DRUG

tapinarof cream, 1%

applied topically once daily

DRUG

Vehicle cream

applied topically once daily

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Diana Villalobos · Dermavant Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-03-30
Completion
2023-04-07
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05014568 on ClinicalTrials.gov