A Phase 2b study looks at the safety and efficacy of a treatment that is being investigated for people with certain diseases. This study will be conducted at multiple centers in the United States where participants with Gorlin Syndrome, also known as basal cell nevus syndrome, will be randomly placed into two groups; one group will receive the active topical gel, the other a topical vehicle gel, also know as placebo. Participants will apply this topical product to their face once a day for 6 months. The study will be looking at the number of new BCCs that develop on the faces of all the participants during this time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
73
QTORIN 3.9 % Sirolimus Topical Gel
Vehicle comparator topical gel
Mayo Clinic
Scottsdale, Arizona, United States
Burke Pharmaceuticals Research
Hot Springs, Arkansas, United States
Stanford Univeristy
Palo Alto, California, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Ameriderm Research
Ormond Beach, Florida, United States
Gwinett Clinical Research Center
Snellville, Georgia, United States
Clinical Coordinating Center (Minnesota)
New Brighton, Minnesota, United States
Mayo Clinic - Minnesota
Rochester, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
...and 6 more locations
Number of new biopsy confirmed BCCs that develop on the face compared between the active and vehicle treatment arms
Time frame: Month 6
Incidence of dermatological, treatment emergent adverse events after treatment with active
Time frame: Month 6
Percentage of participants developing 2 or more new biopsy confirmed BCCs on the face.
Time frame: Month 6
Percentage of participants developing 1 or more new biopsy confirmed BCCs on the face.
Time frame: Month 6
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