Tapinarof for Palmoplantar Keratoderma
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess adults with palmoplantar keratoderma (thickening skin layer on palms and soles) who are treated with the study drug, tapinarof. This is a naturally occuring compound used for the treatment of psoriasis. This study is being done to find out how well and safe this drug is for stopping or treating keratoderma. This study aims to investigate the positive impacts of daily topical Tapinarof use in the improvement of Keratoderma. Clinical efficacy and safety profile of prescribing Tapinarof for this condition will be evaluated.
Will I have to stop taking my current medications?
If you are using topical corticosteroids, keratolytic agents, topical retinoids, topical vitamin D ointment, or oral retinoids, you will need to stop taking them and have a 2-week period without these medications before starting the study.
What data supports the effectiveness of the drug Tapinarof for treating skin conditions?
Is Tapinarof safe for use in humans?
Tapinarof cream has been tested in clinical trials for conditions like plaque psoriasis and has shown a favorable safety profile. Common side effects include folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), and headache, but no new safety concerns were identified in extended trials.12367
How is the drug Tapinarof unique for treating Palmoplantar Keratoderma?
Research Team
David Rosmarin, MD
Principal Investigator
Dermatology
Eligibility Criteria
This trial is for adults with palmoplantar keratoderma, a condition where the skin on palms and soles thickens. Participants should be diagnosed with this condition to qualify. The study will exclude certain individuals based on criteria not specified here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period
Extension
Participants who do not achieve disease clearance continue treatment for up to 36 additional weeks or until clearance is achieved
Follow-up
Participants are monitored for sustained response and recurrence of keratoderma up to 52 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?
Indiana University
Lead Sponsor
Dermavant Sciences, Inc.
Industry Sponsor