RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-30

Study Completion:2026-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06561321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Bhavika Mandi

CONTACT

3172747702

bmandi@iu.edu

Flossy Lincoln

CONTACT

(317) 274-8750

fnjinimb@iupui.edu

Principal Investigator

David Rosmarin, MD

PRINCIPAL_INVESTIGATOR

Dermatology

Study Locations (Sites)

Indiana University Department of Dermatology

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

David Rosmarin, MD, PRINCIPAL_INVESTIGATOR, Dermatology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-30

Study Completion Date2026-02-01

Study Record Updates

Study Start Date2024-10-30

Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

Dermatology

Additional Relevant MeSH Terms

Palmoplantar Keratoderma