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

NCT06561321 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 21197
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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

Palmoplantar Keratoderma

Keywords

Dermatology

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment (PGA)

  To evaluate the treatment benefit of Tapinarof applied topically to patients affected with palmoplantar keratoderma. Either an overall change in the PGA score to 0 (clear) or 1 (almost clear) or a decrease from baseline of at least 2 points. Higher scores indicate a worse outcome. Title: PHYSICIAN GLOBAL ASSESSMENT Minimum value: 0 Maximum value: 5

  Week 16 (Visit 4)

Secondary Outcomes (5)

• Treatment Emergent Adverse Event (TEAEs)

  through study completion, 52 weeks

• Skin assessment every visit

  through study completion, 52 weeks

• Skin pictures at baseline to 52 weeks

  through study completion, 52 weeks

• Patient Global Assessment (PtGA)

  through study completion, 52 weeks

• Dermatology Life Quality Index (DLQI)

  through study completion, 52 weeks

Study Arms (1)

Tapinarof Drug Treatment

EXPERIMENTAL

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.

Drug: Tapinarof

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.

Tapinarof Drug Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Organon and Co: collaborator

Study Sites (1)

Indiana University Department of Dermatology

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Links

• Kerns ML;Hakim JM;Lu RG;Guo Y;Berroth A;Kaspar RL;Coulombe PA; (n.d.). Oxidative stress and dysfunctional Nrf2 underlie Pachyonychia Congenita phenotypes. The Journal of clinical investigation
• Keam, S. J. (2022, August 17). Tapinarof Cream 1%: First approval - drugs. SpringerLink

MeSH Terms

Conditions

Keratoderma, Palmoplantar

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Rosmarin, MD

  Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Austin Routh, MPH, CPH

CONTACT

3172747702; arouth@iu.edu

Flossy Lincoln

CONTACT

(317) 274-8750; fnjinimb@iupui.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Dermatology

Model Details: The treatment duration will span 16 weeks. 1. Following this 16-week period, participants who achieve disease clearance may discontinue the treatment. Patients who stop treatment at 16 weeks will be assessed for their sustained drug response, and their status of clearance will be followed at regularly scheduled visits up to 52 weeks. 2. For those whose condition has not cleared, they will continue with the extension period with the treatment from 16 weeks until their disease becomes clear or until the conclusion of the study (52 weeks), whichever comes first. At the 52-week there will be a follow-up visit for all patients to monitor the response and check if they have maintained their response. As the drug already has a good safety profile and multiple assessments/outcome measures are being implemented, no additional follow-up is necessary but patients will be educated to come in for check-ups if any AEs persist.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-12

Locations

US (1)