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Tapinarof Cream for Plaque Psoriasis in Pediatric Subjects
Study Summary
This trial is testing a new cream to see if it helps kids with plaque psoriasis.
- Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 763 Patients • NCT04053387Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You have a type of psoriasis that is not the most common kind called plaque psoriasis.You have had cancer in the past 5 years, except for certain types of skin or cervical cancers that have been treated successfully.You are not pregnant.You are female and of childbearing potentialYour immune system is weakened at the time of screening.You have had a serious problem with drugs or alcohol within the past year.
- Group 1: Open Label
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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."
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 controlith 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."
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."
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
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