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Topical Cream

Tapinarof Cream for Eczema

Q: Are there still participants needed for this test?

Yes, the trial is still recruiting patients. According to the listings on clinicaltrials.gov, the study was first posted on October 28th, 2021 and was last updated on January 28th, 2022. There are 71 different recruitment sites and the goal is to have 961 participants.

Q: Is Tapinarof cream, 1% effective compared to other treatments?

As of now, there are five ongoing clinical trials for Tapinarof cream, 1%. Out of these five trials, four are in Phase 3. Many of theTapinarof cream, 1% studies are based in Rogers, <a href="https://www.withpower.com/clinical-trials/arkansas">Arkansas</a>, but there are a total of 232 research locations worldwide.

Q: How many guinea pigs are helping researchers with this experiment?

The listing on clinicaltrials.gov verifies that this study is open and recruiting patients. This particular trial was posted on October 28th, 2020 and was last updated on January 28th, 2020. There are 71 sites where this trial is being conducted and 961 patients are needed in total.

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to each visit

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

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

Primary outcome measures

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 outcome measures

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%

Headache

19%

Folliculitis

10%

Back pain

10%

Pruritus

Pain

Pancreatitis

Dehydration

Fatigue

Nausea

Diabetes mellitus

Chest Pain

Abdominal Pain

Nasopharyngitis

Furuncle

pancreatitis

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Tapinarof (DMVT-505) Cream, 1%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dermavant Sciences, Inc.Lead Sponsor

5 Previous Clinical Trials

241 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

Frequently Asked Questions

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

Are there still participants needed for this test?

"Yes, the trial is still recruiting patients. According to the listings on clinicaltrials.gov, the study was first posted on October 28th, 2021 and was last updated on January 28th, 2022. There are 71 different recruitment sites and the goal is to have 961 participants."

Answered by AI

Is Tapinarof cream, 1% effective compared to other treatments?

"As of now, there are five ongoing clinical trials for Tapinarof cream, 1%. Out of these five trials, four are in Phase 3. Many of theTapinarof cream, 1% studies are based in Rogers, Arkansas, but there are a total of 232 research locations worldwide."

Answered by AI

How many guinea pigs are helping researchers with this experiment?

"The listing on clinicaltrials.gov verifies that this study is open and recruiting patients. This particular trial was posted on October 28th, 2020 and was last updated on January 28th, 2020. There are 71 sites where this trial is being conducted and 961 patients are needed in total."

Answered by AI