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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Patidegib Topical Gel, 2%
Patidegib Topical Gel, Vehicle
Axiom Research, LLC
Apple Valley, California, United States
Axiom Research, LLC
Colton, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Dermatology Research Associates
Los Angeles, California, United States
The Dermatology Center of Newport
Newport Beach, California, United States
Palm Beach Dermatology Research
Delray Beach, Florida, United States
Leavitt Medical Associates of Florida
Ormond Beach, Florida, United States
PellePharm Investigative Site
Saint Augustine, Florida, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Grekin Skin Institute
Warren, Michigan, United States
...and 4 more locations
Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)
Time frame: Up to 9 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that started on or after the first dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Time frame: Up to 9 months
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