Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561321
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Phase II Study to Evaluate the Clinical Efficacy and Safety of Tapinarof for Adult Patients With Palmoplantar Keratoderma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
This study aims to assess the benefits of the treatment Should the treatment demonstrate benefits as defined by the primary outcome measure without any observed serious adverse events SAEs further clinical trials would be justified If at least 2 out of 6 subjects benefits from the treatment as defined by our primary outcome measure and there are no SAEs future clinical trials would be warranted This initial data will determine whether it is worthwhile to proceed with a phase 2 trial that will be both blinded and well-controlled
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None