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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
Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8
Awards & highlights

Study Summary

This trial is testing a new cream for atopic dermatitis (a skin condition). The cream will be compared to a placebo cream to see if it is more effective and safe.

Eligible Conditions
  • Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are capable of giving informed consent/assent.
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You have atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old.
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You are male or female and you have clinical diagnosis of Alzheimer's disease.
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The given statement is not a screening criterion. It is a question to gather information about a person's height.
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This criterion doesn't require simplification as it is already plain and simple.
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If you are a woman who could become pregnant and are sexually active, you must use birth control that is considered safe and effective.
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You cannot be pregnant.
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You have atopic dermatitis that affects between 5% to 35% of your body surface area.
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You have a score of 3 or higher on a test called vIGA-AD during screening and baseline evaluations.
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You have a skin condition with an EASI score of 6 or higher at screening and baseline.

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
2,719 Total Patients Enrolled
Michael McLaughlinStudy DirectorDermavant Sciences GmbH
2 Previous Clinical Trials
54 Total Patients Enrolled
Diana VillalobosStudy DirectorDermavant Sciences, Inc.
4 Previous Clinical Trials
1,503 Total Patients Enrolled

Frequently Asked Questions

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

Please list the number of healthcare facilities where this experiment is taking place.

"Presently, this clinical trial is enrolling patients at 77 sites. The locations of these clinics are situated in cities such as Knoxville, Dallas and Garden City. If you choose to enroll in the trial, it would be helpful to select a clinic nearest to your home to limit travel requirements."

Answered by AI

Has the FDA acknowledged tapinarof cream, 1% as a safe medication?

"There is enough evidence from both Phase 3 trials as well as other data sources to support the safety of tapinarof cream, 1%."

Answered by AI

How many individuals are included in this clinical trial?

"The clinical trial is actively recruiting participants, with the most recent update on 1/28/2022. The posting for the trial was 9/1/2021. They are looking for 400 participants between 77 sites."

Answered by AI

Are the results of this tapinarof cream study in line with other research?

"There are five ongoing studies involving tapinarof cream, 1%. Of these clinical trials, four are in Phase 3. The city of Rogers, Arkansas has the most medical centres running these tests; however, there are a total of 232 locations across the world conducting these experiments."

Answered by AI

Are you currently looking for participants in this research?

"That is correct. The website clinicaltrials.gov has the most recent information regarding this study, which shows that it is presently recruiting patients. This trial was first posted on September 1st, 2021 and was last edited on January 28th, 2022. There are 77 sites enrolling 400 participants in total."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
California
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?
Did not meet criteria
Met criteria
~116 spots leftby Mar 2025