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Topical Agent

tapinarof cream, 1% for Atopic Dermatitis

Phase 3
Waitlist Available
Research Sponsored by Dermavant Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8
Awards & highlights
Pivotal Trial

Summary

This trial tests a medicated cream called tapinarof on children and adults with itchy, inflamed skin. The cream aims to reduce redness and itching by calming the skin's reaction. Participants will use the cream daily for a period of time, with an option for extended treatment.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
Mean change in in Percent of Total Body Surface Area (%BSA) affected from Baseline to Week 8.
Percent of subjects with ≥ 75% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.
Percent of subjects with ≥ 90% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.
+1 more

Side effects data

From 2021 Phase 3 trial • 763 Patients • NCT04053387
23%
Folliculitis
6%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: tapinarof creamExperimental Treatment1 Intervention
tapinarof cream, 1%, applied topically once daily
Group II: vehicle creamPlacebo Group1 Intervention
vehicle cream, applied topically once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tapinarof cream, 1%
2021
Completed Phase 3
~1580

Find a Location

Who is running the clinical trial?

Dermavant Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
1,615 Total Patients Enrolled
Dermavant Sciences GmbHLead Sponsor
12 Previous Clinical Trials
2,720 Total Patients Enrolled
Diana VillalobosStudy DirectorDermavant Sciences, Inc.
4 Previous Clinical Trials
1,504 Total Patients Enrolled
~99 spots leftby Nov 2025
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