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Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months

Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months

Patidegib Topical Gel, 2%

Patidegib Topical Gel, Vehicle

VP, Clinical Operations

This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs.

Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender.

As a double-blinded study, the Investigators, the site staff, PellePharm, and the Clinical Monitor(s) will be blinded to the treatment assigned to individual subjects. Delegated staff members at the study site will dispense the investigational product (IP) and will collect and weigh all used and unused IP tubes.

An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC

A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients With Non-Gorlin High Frequency BCC

Sol-Gel Technologies, Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC	NCT04155190	Recurrent Basal...	Patidegib Topic... Patidegib Topic...	18 Years -	Sol-Gel Technologies, Ltd.
An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC	NCT04155190	Recurrent Basal...	Patidegib Topic... Patidegib Topic...	18 Years -	Sol-Gel Technologies, Ltd.

Spots Global Cancer Trial Database for recurrent basal cell carcinoma