Evaluating Tapinarof for treating thick skin on palms and soles

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

This study is testing if a new cream called Tapinarof can help adults with thick skin on their palms and soles feel better and improve their condition.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT06561321 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and efficacy of Tapinarof, a naturally occurring compound, in adults diagnosed with palmoplantar keratoderma, a condition characterized by thickened skin on the palms and soles. Participants will apply Tapinarof daily, and the study aims to evaluate its clinical benefits and safety profile. The results will help determine if further, more extensive trials are warranted based on the observed effects and any adverse events. This initial phase is crucial for gathering data to inform future randomized controlled trials.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of palmoplantar keratoderma.

Not a fit: Patients currently using topical corticosteroids, keratolytic agents, or other specified treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from palmoplantar keratoderma.

How similar studies have performed: While this approach is novel for palmoplantar keratoderma, similar studies using Tapinarof for psoriasis have shown promising results.

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.

Where this trial is running

Indianapolis, Indiana

• Indiana University Department of Dermatology — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: David Rosmarin, MD — Dermatology
• Study coordinator: Austin Routh, MPH, CPH

Conditions Palmoplantar Keratoderma; Dermatology