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

Led by Indiana University · Updated on 2026-06-23

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

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
- 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.

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

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AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria