A Phase 3 interventional study of Patidegib Topical Gel and Patidegib Topical Gel with no active patidegib in Gorlin Syndrome, sponsored by Sol-Gel Technologies, Ltd.. Completed at 40 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Sol-Gel Technologies, Ltd. · Phase 3, Interventional, and Prevention
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.
People who take part 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 those who used Patidegib Gel 2% or Vehicle Gel after 12 months.
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 subjects with Gorlin syndrome.
Subjects will be randomized (1:1) to receive either Patidegib Gel 2% or Vehicle Gel for 12 months.
The assignment of subjects to the 2 groups will be stratified by sex assigned at birth, age (≥60 or \<60 years), and number of BCC lesions at the treatment area (face) (10-15, 16-30 or >30) at Baseline.
All suspicious lesions will be imaged and tracked consistently throughout the study so that new BCCs that arise can be readily identified. New BCCs will be confirmed by dermoscopic analysis through the study. The BCC images will be reviewed and assessed by a Central Photo Review Board (CPRB).
35 studies on the registry are indexed under Basal Cell Nevus Syndrome; 4 are open to participants now.
This study's enrollment of 113 is above the median of 24 across 25 interventional studies indexed under Basal Cell Nevus Syndrome.
Browse Basal Cell Nevus Syndrome studies →Sol-Gel Technologies, Ltd. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months
Drug: Patidegib Topical Gel
Vehicle Gel, applied topically to the face twice daily for 12 months
Drug: Patidegib Topical Gel with no active patidegib
Patidegib Gel 2% is a smooth, clear, colorless-to-yellow, viscous, hydro-alcoholic gel for topical administration.
Also known as: Patidegib, IPI-926, Saridegib, SGT-610
Vehicle Gel consists of the excipients of Patidegib Gel with no active patidegib. It is a smooth viscous gel for topical administration.
Also known as: Vehicle Gel, Placebo
Number of new BCCs on the face at Month 12
New BCCs at Month 12 in the Patidegib Gel 2% and Vehicle Gel groups, as assessed by the CPRB
Time frame: Month 12
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Aug 2026, 29 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Patidegib Topical Gel
Sol-Gel Technologies, Ltd.