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Pelle-926-301 Patidegib Topical Gel For BCNS - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study gel (Patidegib) reduces the number of basal cell carcinomas when applied to the face twice a day.
What is the Condition Being Studied?
Basal Cell Nevus (Gorlin) Syndrome

Who Can Participate in the Study?

Adults who:
- Have (or be suspected of having) basal cell nevus (Gorlin) syndrome
- Have had at least 3 basal cells on the face within the last 24 months

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be assigned (like the flip of a coin) to either get the study gel (Patidegib) or a gel that doesn't have any drug in it
- Be asked to apply the gel twice a day for 12 months
- Be asked to come for 14 study visits and be available for 1 study phone call with the study team
- Have your skin looked at by the study doctor
- Have a series of blood and urine tests
- Have your skin photographed
- Answer questionnaires
- Let the study doctor take samples of tissue from basal cell carcinomas

Study Details

Full Title
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome
Principal Investigator
Protocol Number
IRB: PRO00101273
NCT: NCT03703310
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698