Study on Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face in Adults with Gorlin Syndrome

Sponsor: Sol-Gel Technologies, Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06050122

Provider View

This clinical trial is testing how well Patidegib Gel 2% can prevent new basal cell skin cancers from forming on the faces of adults with Gorlin syndrome, and how safe it is to use.

Patient Parameters

Program Overview

The purpose of this study is to see if Patidegib Gel 2% can help stop new basal cell skin cancers from developing on the faces of adults with Gorlin syndrome. Participants will apply either Patidegib Gel 2% or a gel without the active drug to their face twice a day for one year. The study will compare the number of new skin cancers between those using Patidegib Gel and those using the inactive gel after 12 months.

Description

This study is being conducted in multiple locations around the world and involves adult participants with Gorlin syndrome. It is designed to test the effectiveness and safety of Patidegib Gel 2% when applied to the face twice daily.

Participants will be randomly assigned to one of two groups: one group will use Patidegib Gel 2%, and the other will use a gel without the active drug. This assignment will be based on factors like sex, age (whether they are 60 or older), and the number of basal cell skin cancers on their face at the start of the study.

Throughout the study, all existing and new basal cell skin cancers will be photographed and monitored. Any new skin cancers will be confirmed using a special skin examination technique called dermoscopy.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Must have a confirmed PTCH1 gene mutation.
  • Must have at least 10 basal cell skin cancers on the face at the start of the study.
  • Must agree not to use any other skin medications on the face during the study, unless prescribed by the study doctor.

Exclusion Criteria

  • Have used other skin treatments or medications that might affect the study results.
  • Have allergies to any ingredients in the study gel.
  • Have uncontrolled health conditions.
  • Have been treated for invasive cancer in the past 5 years, except for certain early-stage cancers.
  • Have previously used a similar type of medication that did not work for reasons other than side effects.

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