Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma
NCT Number: NCT06561321
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Palmoplantar Keratoderma
Interventions: DRUG: Tapinarof
Sponsor: Indiana University
Collaborators: Dermavant Sciences, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2026-02-01
Locations: Indiana University Department of Dermatology, Indianapolis, Indiana, 46202, United States

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.

Primary Outcome Measures: Physician's Global Assessment (PGA), To evaluate the treatment benefit of Tapinarof applied topically to patients affected with palmoplantar keratoderma.

Either an overall change in the PGA score to 0 (clear) or 1 (almost clear) or a decrease from baseline of at least 2 points. Higher scores indicate a worse outcome.

Title: PHYSICIAN GLOBAL ASSESSMENT Minimum value: 0 Maximum value: 5, Week 16 (Visit 4)
Secondary Outcome Measures: Treatment Emergent Adverse Event (TEAEs), To assess the safety of Tapinarof applied topically to patients affected with palmoplantar keratoderma.

Frequency and severity of treatment emergent adverse events (TAEs)., through study completion, 52 weeks|Skin assessment every visit, To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the investigator.

Skin assessment of the affected areas, palms and/or soles, that are being managed with topical Tapinarof., through study completion, 52 weeks|Skin pictures at baseline to 52 weeks, To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the investigator.

To identify and note any visible differences due to the application of Tapinarof, throughout the treatment phase from baseline, 4 weeks, end of primary endpoint and lastly at the end of the monitoring phase at 52 weeks., through study completion, 52 weeks|Patient Global Assessment (PtGA), To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the patient.

Note any patient reported outcomes and patient satisfaction of the treatment through a standardized Patient Global Assessment (PtGA) questionnaire. Higher scores indicate a worse outcome.

Title: PATIENT GLOBAL ASSESSMENT Minimum value: 0 Maximum value: 5, through study completion, 52 weeks|Dermatology Life Quality Index (DLQI), To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the patient. Done to monitor patient's observation and impact of Tapinarof use to their quality of life. Higher scores indicate a worse outcome.

Title: DERMATOLOGY LIFE QUALITY INDEX Minimum value: 0 Maximum value: 30, through study completion, 52 weeks