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Topical Agent

tapinarof cream, 1% for Atopic Dermatitis

Phase 3
Waitlist Available
Research Sponsored by Dermavant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects ages 2 and above with clinical diagnosis of AD
Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8
Awards & highlights

Study Summary

This trial is testing whether a new cream is better than the standard cream for treating atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are 2 years or older and have been diagnosed with atopic dermatitis.
Select...
You have eczema that affects between 5% to 35% of your body surface area.
Select...
You have had eczema for at least 6 months (if you're 6 years old or older) or 3 months (if you're between 2 and 5 years old).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared tapinarof cream, 1% for use?

"There is both anecdotal and clinical evidence supporting the safety of tapinarof cream, 1%, which our team has rated a 3."

Answered by AI

How many people are involved in this research project?

"That is correct, the clinical trial is currently recruiting patients. The original posting was on September 23rd, 2021 and there have been subsequent edits made on January 28th, 2022. In total, 400 participants are needed from 72 different locations."

Answered by AI

Has tapinarof cream, 1% been studied before in other clinical trials?

"The first study evaluating the efficacy of tapinarof cream, 1% was completed in 2021 at Peking University People's Hospital. As of now, a total of 16 clinical trials have been completed with 5 more currently underway. Many of these studies are being conducted out of Scottsdale, Arizona."

Answered by AI

Is this research being conducted in multiple hospitals across North America?

"This study is currently running at 72 sites. The sites are located in Scottsdale, Las Vegas and Spartanburg as well as other cities 72 other locations. To minimize travel requirements, you should select the location nearest to you if you decide to enroll in this trial."

Answered by AI

Are we still able to sign patients up for this clinical experiment?

"Yes, this information is accurate. The clinical study in question was originally posted on September 23rd 2021 and updated most recently on January 28th of this year."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Kentucky
Texas
How old are they?
18 - 65
What site did they apply to?
Dermavant Clinical Trial
Dermavant Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Nothing so far has helped.
PatientReceived no prior treatments
~116 spots leftby Mar 2025