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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06561321
Phase
PHASE2
Status
Recruiting
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Conditions

  • Palmoplantar Keratoderma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tapinarof — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 30, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tapinarof Drug Treatment
    Subjects in this arm will apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period. Participants who achieve disease clearance after 16 weeks may discontinue treatment and will be monitored for sustained response up to 52 weeks. Those who do not achieve clearance will continue the treatment during an extension period for up to 36 additional weeks or until clearance is achieved, whichever comes first. Regular follow-up visits will assess the duration of disease clearance and monitor for any potential recurrence of keratoderma.

Primary Outcome Measure

Physician's Global Assessment (PGA) [ Time Frame: Week 16 (Visit 4) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Department of DermatologyIndianapolisIndiana46202
Austin Routh, MPH, CPH
[email protected]
317-274-7702
Flossy Lincoln
[email protected]
317-274-8750
David Rosmarin, MD (PRINCIPAL_INVESTIGATOR)
Bhavika Mandi, MBBS, MHA (SUB_INVESTIGATOR)
Catarina Daffre, DNP, FNP-BC (SUB_INVESTIGATOR)
Mary Combs, NP (SUB_INVESTIGATOR)

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By research site
Indiana University Department of Dermatology· Indianapolis, IN

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