NCT06561321

Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma

An Open-label, Phase II Study to Evaluate the Clinical Efficacy and Safety of Tapinarof for Adult Patients With Palmoplantar Keratoderma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 experiences that can be used to design subsequent, well-controlled studies that are appropriately powered for statistical analysis. Currently, there is not enough experience with this medication in treating this specific condition, which is necessary to design successful randomized controlled trials (RCTs) for regulatory approval by the FDA. In dermatology, conducting studies in this manner is standard practice.

Conditions

• Palmoplantar Keratoderma

Interventions

Type	Name	Description
DRUG	Tapinarof	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.

Timeline

• Start date: 2024-10-30
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-08-20
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study