Back to resultsEfficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
Primary Purpose
Gorlin Syndrome
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Patidegib Topical Gel
Vehicle Gel
Sponsored by
About this trial
This is an interventional prevention trial for Gorlin Syndrome
Eligibility Criteria
Key Inclusion Criteria: The subject must be at least 18 years old at the Screening Visit. The subject must be confirmed to have positive PTCH1 mutation. The subject must have had at least 15 clinically typical BCCs present on the face within 24 months prior to randomization. The subject must have at least 10 BCCs on the face at Baseline/Day 1. The subject must be willing to abstain from application of any topical medication (prescription or over the counter) to facial skin for the duration of the trial. Key Exclusion Criteria: The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP). The subject is known to have hypersensitivity to any of the ingredients in the IP. The subject has uncontrolled systemic disease. The subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia Stage 0 and non-melanoma skin cancer, Stage I cervical cancer, or ductal carcinoma in situ of the breast. Previous Hedgehog inhibitor therapy was considered to have failed for reasons other than unfavorable side effect(s).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patidegib Gel 2%
Vehicle Gel
Arm Description
Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months
Vehicle Gel, applied topically to the face twice daily for 12 months
Outcomes
Primary Outcome Measures
Number of new BCCs on the face at Month 12
New BCCs, confirmed through dermoscopy, at Month 12 after twice-daily treatment with either Patidegib Gel 2% or Vehicle Gel for 12 months
Secondary Outcome Measures
Full Information
NCT ID
NCT06050122
First Posted
September 15, 2023
Last Updated
September 15, 2023
Sponsor
Sol-Gel Technologies, Ltd.
Collaborators
Premier Research Group plc
1. Study Identification
Unique Protocol Identification Number
NCT06050122
Brief Title
Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
Official Title
A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Gorlin Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sol-Gel Technologies, Ltd.
Collaborators
Premier Research Group plc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this clinical study is to find out how well Patidegib Gel 2% works in preventing new basal cell carcinomas (BCCs) developing on the face of adults with Gorlin syndrome, and how safe Patidegib Gel 2% is to use.
Participants will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between participants who used Patidegib Gel 2% or Vehicle Gel after 12 months.
Detailed Description
This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Gel 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome.
Participants will be randomized (1:1) to receive either Patidegib Gel 2% or Vehicle Gel for 12 months. The assignment of participants to the 2 groups will be stratified by gender, age (≥60 or <60 years), and number of facial BCC lesions (10-15, 16-30 or >30) at baseline.
All BCCs at baseline, and any new BCCs which develop during the study, will be photographed and tracked during the study. New BCCs will be confirmed by dermoscopy analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gorlin Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patidegib Gel 2%
Arm Type
Experimental
Arm Description
Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel, applied topically to the face twice daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Patidegib Topical Gel
Other Intervention Name(s)
Patidegib, IPI-926, Saridegib, SGT-610
Intervention Description
Patidegib Gel 2% is a smooth, clear, colorless-to-yellow, viscous, hydro-alcoholic gel for topical administration.
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
Vehicle Gel consists of the excipients of Patidegib Gel with no active patidegib. It is a smooth viscous gel for topical administration.
Primary Outcome Measure Information:
Title
Number of new BCCs on the face at Month 12
Description
New BCCs, confirmed through dermoscopy, at Month 12 after twice-daily treatment with either Patidegib Gel 2% or Vehicle Gel for 12 months
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
The subject must be at least 18 years old at the Screening Visit.
The subject must be confirmed to have positive PTCH1 mutation.
The subject must have had at least 15 clinically typical BCCs present on the face within 24 months prior to randomization.
The subject must have at least 10 BCCs on the face at Baseline/Day 1.
The subject must be willing to abstain from application of any topical medication (prescription or over the counter) to facial skin for the duration of the trial.
Key Exclusion Criteria:
The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP).
The subject is known to have hypersensitivity to any of the ingredients in the IP.
The subject has uncontrolled systemic disease.
The subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia Stage 0 and non-melanoma skin cancer, Stage I cervical cancer, or ductal carcinoma in situ of the breast.
Previous Hedgehog inhibitor therapy was considered to have failed for reasons other than unfavorable side effect(s).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vice President of Clinical Affairs
Phone
972-8-9313433
Email
info@sol-gel.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
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