Tapinarof Cream for Plaque Psoriasis
Trial Summary
What is the purpose of this trial?
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Will I have to stop taking my current medications?
The trial information does not clearly state if you need to stop taking your current medications. However, it mentions that the use of any prohibited medication is not allowed during the study, so you may need to discuss your current medications with the study team.
Is Tapinarof cream safe for human use?
Tapinarof cream has been shown to be generally safe for human use, with common side effects including folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), headache, and upper respiratory tract infection. These findings are based on clinical trials for plaque psoriasis, and no new safety concerns were identified in extended studies.12345
How is the drug Tapinarof cream unique for treating plaque psoriasis?
Tapinarof cream is unique because it is a topical treatment that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin health. Unlike traditional treatments like corticosteroids, it offers a novel mechanism of action with promising results in clinical trials.13567
Research Team
Diana Villalobos
Principal Investigator
Dermavant Sciences, Inc.
Eligibility Criteria
This trial is for children and teens aged 2 to 17 with chronic plaque psoriasis covering at least 3% of their body. They must have had stable disease for the past three months, not be pregnant or immunocompromised, and have normal liver function tests. Girls who can get pregnant must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tapinarof cream, 1% once daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term extension (optional)
Participants may opt into continuation of treatment with tapinarof cream for an additional 40 weeks
Treatment Details
Interventions
- Tapinarof
Tapinarof is already approved in United States for the following indications:
- Plaque psoriasis in adults
- Atopic dermatitis in adults and pediatric patients 2 years of age and older
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dermavant Sciences, Inc.
Lead Sponsor