Actively Recruiting
An Open-label, Phase II Study to Evaluate the Clinical Efficacy and Safety of Tapinarof for Adults With Palmoplantar Keratoderma
Led by Indiana University · Updated on 2026-03-04
6
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
O
Organon and Co
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of tapinarof, a naturally occurring compound used in psoriasis treatment, on adults with palmoplantar keratoderma, a condition characterized by thickened skin on the palms and soles. This phase II open-label study aims to evaluate how well tapinarof works and how safe it is for treating or stopping keratoderma. The study will gather early data to guide future controlled trials needed for regulatory approval. Participants will apply tapinarof 1% cream to affected areas once daily for a 16-week treatment period. Those who achieve disease clearance after 16 weeks may stop treatment and will be monitored for up to 52 weeks to see if the condition returns. Participants who do not clear the disease will continue treatment for up to an additional 36 weeks or until clearance is reached. Follow-up visits throughout the study assess treatment response and safety. During the study, participants will have regular skin assessments, photographs, and complete questionnaires about their skin condition and quality of life. Researchers will measure outcomes using the Physician's Global Assessment at 16 weeks and monitor for any treatment-related side effects throughout the 52-week study period. The study involves ongoing evaluation of skin health and patient-reported outcomes to understand the treatment's impact and safety.
CONDITIONS
Brief Title
Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent and follow all study requirements
- Male or female adults aged 18 years or older
- Confirmed clinical diagnosis of palmoplantar keratoderma
You will not qualify if you...
- Use of topical corticosteroids, keratolytic agents, topical retinoids, topical vitamin D ointment, or oral retinoids without at least a 2-week washout before the study
- Prior treatment with tapinarof
- History or suspicion of allergic reactions to tapinarof or similar drugs
- Current participation in another clinical study for the same purpose
- Pregnancy or confirmed pregnancy at screening
- Any other conditions that investigators consider make the participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks, with possible extension up to 52 weeks
Participants apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period. Those who do not achieve disease clearance may continue treatment for up to 36 additional weeks or until clearance is achieved.
Regular visits during treatment period
Duration - Up to 52 weeks
Participants who achieve disease clearance after treatment are monitored for sustained response and potential recurrence of keratoderma.
Regular follow-up visits up to 52 weeks
Trial Site Locations
Total: 1 location
1
Indiana University Department of Dermatology
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Austin Routh, MPH, CPH
F
Flossy Lincoln
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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