Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma
NCT ID: NCT06561321
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
6 participants
INTERVENTIONAL
2024-10-30
2026-11-01
Brief Summary
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Detailed Description
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The study is designed to gather preliminary experiences that can be used to design subsequent, well-controlled studies that are appropriately powered for statistical analysis. Currently, there is not enough experience with this medication in treating this specific condition, which is necessary to design successful randomized controlled trials (RCTs) for regulatory approval by the FDA. In dermatology, conducting studies in this manner is standard practice.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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Tapinarof Drug Treatment
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.
Tapinarof
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.
Interventions
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Tapinarof
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Dermavant Sciences, Inc.
INDUSTRY
Indiana University
OTHER
Responsible Party
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David Rosmarin
Chair, Department of Dermatology
Principal Investigators
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David Rosmarin, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology
Locations
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Indiana University Department of Dermatology
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Bhavika Mandi
Role: primary
Flossy Lincoln
Role: backup
Related Links
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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
Other Identifiers
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21197
Identifier Type: -
Identifier Source: org_study_id