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Topical Agent

Tapinarof Cream for Plaque Psoriasis in Pediatric Subjects

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

Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline

A PGA score of ≥ 2 at screening and baseline

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upweek 4 and week 12

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Study Summary

This trial is testing a new cream to see if it helps kids with plaque psoriasis.

Eligible Conditions

Plaque Psoriasis

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 and week 12 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 (AEs) and Serious Adverse Events (SAEs)

Investigator-Assessed Local Tolerability Scale (LTS) Scores

Number of subjects with clinically significant laboratory test abnormalities

+2 more

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.

Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.

Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.

Side effects data

From 2021 Phase 3 trial • 763 Patients • NCT04053387

23%

Folliculitis

Dermatitis contact

100%

80%

60%

40%

20%

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.

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: Open LabelExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tapinarof cream, 1%

2021

Completed Phase 3

~1580

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dermavant Sciences, Inc.Lead Sponsor

5 Previous Clinical Trials

1,102 Total Patients Enrolled

Diana VillalobosStudy DirectorDermavant Sciences, Inc.

4 Previous Clinical Trials

1,810 Total Patients Enrolled

Media Library

Tapinarof (Topical Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05172726 — Phase 3

Plaque Psoriasis Research Study Groups: Open Label

Plaque Psoriasis Clinical Trial 2023: Tapinarof Highlights & Side Effects. Trial Name: NCT05172726 — Phase 3

Tapinarof (Topical Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05172726 — 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 any restrictions on where this clinical trial can be accessed?

"This study is looking for participants from 11 different locations, which are listed on the website. If you are considering participating, it might be helpful to choose a site that is close to your home to avoid extra travel."

Answered by AI

At what age does this trial cutoff for participants?

"According to the study's inclusion criteria, patients between the ages of 2 and 17 are eligible to participate. There are a total of 36 trials for people under 18 and 159 for people over 65."

Answered by AI

How many people are being selected to participate in this research?

"Yes, the information on clinicaltrials.gov says that this trial is currently searching for candidates. The study was originally posted on December 2nd, 2021 and was most recently edited on February 23rd, 2022. The trial is looking for 100 participants at 11 sites."

Answered by AI

Are the results of this study on tapinarof cream, 1% in line with previous research?

"5 clinical trials for tapinarof cream, 1% are currently active, with 4 of those being Phase 3 trials. Rogers, Arkansas is the location for many of the trials, but there are a total of 232 sites running trials for this cream."

Answered by AI

Are there any short or long-term risks associated with tapinarof cream, 1%?

"There is some evidence of efficacy and extensive safety data available, so our team at Power gave tapinarof cream, 1% a score of 3."

Answered by AI

Which types of people would be able to join this research project?

"The aim of this study is to enrol 100 individuals with psoriasis aged 2-17. To be eligible, patients must: be male or female, have had the disease for 3 months or more, have plaque psoriasis covering 3% or more of their body, have a PGA score of 2 or more, not be pregnant, and use birth control ith psoriasis aged 2-17. To be eligible, patients must: be male or female, have had the disease for 3 months or more, have plaque psoriasis covering 3% or more of their body, have a PGA score of 2 or more, not be pregnant, and use birth control if they are sexually active and of childbearing age."

Answered by AI

Are new participants still being welcomed into this research project?

"Correct, the listed clinical trial on clinicaltrials.gov is actively recruiting patients. The posting date was December 2nd, 2021 and the most recent update was on February 23rd, 2022. They are looking for 100 patients that can visit one of the 11 locations."

Answered by AI