Status:
RECRUITING
Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Dermavant Sciences, Inc.
Conditions:
Palmoplantar Keratoderma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 comp...
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), furth...
Eligibility Criteria
Inclusion
- 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
- 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
- Topical vitamin D ointment (calcipotriol)
- Oral retinoids (acitretin)
- If on any of these then a washout period of at least 2 weeks will be enforced before the study begins. This washout period is meant to ensure that any effects or residues from previous treatments are minimized before starting the study.
- Prior exposure to Tapinarof treatment
- Known history or suspicion of hypersensitivity reactions, or contraindications to any or all components of the drug or drugs of similar properties.
- Currently participating in another clinical study for the same purpose.
- Potential or confirmed pregnancy: Individuals who are currently pregnant or have confirmed pregnancy at the time of screening will be excluded from participation in the study. This criterion aims to ensure the safety of participants and adhere to ethical considerations regarding the potential risks associated with the study interventions during pregnancy.
- Any other factors specifically not listed above but deemed patient unsuitable by the discretion of the investigators.
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06561321
Start Date
October 30 2024
End Date
November 1 2026
Last Update
December 20 2024
Active Locations (1)
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1
Indiana University Department of Dermatology
Indianapolis, Indiana, United States, 46202