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Topical Cream

Tapinarof Cream for Eczema

Phase 3
Recruiting
Research Sponsored by Dermavant Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Roll-over Subjects Only: Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study). Must not be pregnant at Baseline
For Direct-Enrolling Subjects Only: Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD. Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria. AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old. Must not be pregnant at Screening or Baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to each visit
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of a new cream for treating atopic dermatitis, a chronic skin condition. The trial will last up to 48 weeks and include follow-up appointments.

Who is the study for?
This trial is for individuals, including children as young as 2 years old, with atopic dermatitis (eczema). Participants must have had the condition for a minimum of 3 to 6 months depending on age. Women who can become pregnant must use birth control. Those previously in certain related studies or failing initial study criteria may also join.
What is being tested?
The trial tests Tapinarof cream, 1%, over up to 48 weeks to assess its long-term safety and effectiveness in treating atopic dermatitis. It's an open-label study where everyone receives the treatment and includes subjects from previous phase trials or new enrollees.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with topical treatments like Tapinarof cream could include skin irritation, redness, itching or burning sensation at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events and Serious Adverse Events
Mean Investigator- and Subject (or Caregiver)-assessed LTS scores by visit
Number of subjects with clinically significant laboratory test abnormalities
+1 more
Secondary study objectives
Absolute value, change and percent change from Baseline in %BSA affected by visit
Absolute value, change and percent change from Baseline in Eczema Area and Severity Index (EASI) score by visit
Mean change in PP- NRS score
+5 more

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT04042103
19%
Folliculitis
19%
Headache
10%
Back pain
10%
Pruritus
5%
Chest Pain
5%
Fatigue
5%
Pain
5%
pancreatitis
5%
Abdominal Pain
5%
Nausea
5%
Pancreatitis
5%
Furuncle
5%
Diabetes mellitus
5%
Nasopharyngitis
5%
Dehydration
5%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tapinarof (DMVT-505) Cream, 1%

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: tapinarof creamExperimental Treatment1 Intervention
Tapinarof 1%, cream
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tapinarof cream, 1%
2021
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Dermavant Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
1,060 Total Patients Enrolled
Diana VillalobosStudy DirectorDermavant Sciences, Inc.
4 Previous Clinical Trials
949 Total Patients Enrolled

Media Library

Tapinarof cream, 1% (Topical Cream) Clinical Trial Eligibility Overview. Trial Name: NCT05142774 — Phase 3
Atopic Dermatitis Research Study Groups: tapinarof cream
Atopic Dermatitis Clinical Trial 2023: Tapinarof cream, 1% Highlights & Side Effects. Trial Name: NCT05142774 — Phase 3
Tapinarof cream, 1% (Topical Cream) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142774 — Phase 3
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05142774 — Phase 3
~240 spots leftby Nov 2025
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