An Open-label, Phase II Study to Evaluate the Clinical Efficacy and Safety of Tapinarof for Adult Patients With Palmoplantar Keratoderma
Indiana University
Summary
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.
Description
This study aims to assess the benefits of the treatment. Should the treatment demonstrate benefits (as defined by the primary outcome measure) without any observed serious adverse events (SAEs), further clinical trials would be justified. If at least 2 out of 6 subjects benefits from the treatment (as defined by our primary outcome measure) and there are no SAEs, future clinical trials would be warranted. This initial data will determine whether it is worthwhile to proceed with a phase 2 trial, that will be both blinded and well-controlled. The study is designed to gather preliminary experien…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to discern and provide written informed consent and voluntarily adhere to all of the protocol requirements * Male or female subjects in their adult years (≥ 18 years of age), inclusive, from the time of providing written subject-investigator agreement. * Confirmed clinical diagnosis of palmoplantar keratoderma. Exclusion Criteria: * Treatment with any of the following medications and therapies during the duration of the study\*: * Topical corticosteroids * Keratolytic agents (eg, 6% salicylic acid, 70% propylene glycol, 30% water) * Topical retinoids *…
Interventions
- DrugTapinarof
Daily topical Tapinarof use will stop disease advancement and improve the quality of life in patients with palmoplantar keratoderma, through its AhR \& NRF2 agonism properties.
Location
- Indiana University Department of DermatologyIndianapolis, Indiana