tapinarof cream, 1% for Plaque Psoriasis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dermavant Clinical Site, Rogers, ARPlaque Psoriasistapinarof cream, 1% - Drug
Eligibility
2 - 17
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Plaque Psoriasis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: Week 4 and Week 12

Week 52
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Week 53
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects with clinically significant laboratory test abnormalities
Number of subjects with clinically significant vital signs abnormalities
Week 12
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%.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score
23%Folliculitis
6%Dermatitis contact
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04053387) in the Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score ARM group. Side effects include: Folliculitis with 23%, Dermatitis contact with 6%.

Trial Design

1 Treatment Group

Open Label
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: tapinarof cream, 1% · No Placebo Group · Phase 3

Open Label
Drug
Experimental Group · 1 Intervention: tapinarof cream, 1% · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tapinarof
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 4 and week 12

Who is running the clinical trial?

Dermavant Sciences, Inc.Lead Sponsor
3 Previous Clinical Trials
1,027 Total Patients Enrolled
Diana VillalobosStudy DirectorDermavant Sciences, Inc.
4 Previous Clinical Trials
1,797 Total Patients Enrolled

Eligibility Criteria

Age 2 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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 if they are sexually active and of childbearing age." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.