Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tapinarof cream, 1% — DRUG
  applied topically once daily
• Vehicle cream — DRUG
  applied topically once daily

Study Details

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.

Key Dates

Start date

Sep 1, 2021

Status verified

Aug 2025

Primary completion

Mar 30, 2023

Completion

Apr 7, 2023

Study Design

Enrollment

407 participants (actual)

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, applied topically once daily

Primary Outcome Measure

Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation. [ Time Frame: Baseline to Week 8 ]

Locations (60)

Find similar trials in Birmingham, AL

Related Studies

• Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
  Recruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
• Studies of Skin Microbes in Healthy People and in People With Skin Conditions
  Recruiting · National Human Genome Research Institute (NHGRI) · Bethesda, Maryland
• Natural History and Genetics of Food Allergy and Related Conditions
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
• Skin Microbial Ecology in Atopic Dermatitis
  Recruiting · University of Rochester · Rochester, New York