CODY (Basal Cell Carcinoma in Gorlin Syndrome) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental, topical (applied to the skin) formulation of rapamycin, PTX-022, is a safe and effective treatment for Gorlin Syndrome. We want to know if this study drug can prevent new basal cell carcinomas on the face.

What is the Condition Being Studied?

Basal Cell Carcinomas in People with Gorlin Syndrome

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with Gorlin Syndrome
- Have a history of having basal cell carcinoma on their face

For more information about who can join this study, please contact the study team at connor.whatley@duke.edu or 919-681-8368.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:
- Visit our clinic 5 times
- Have physical exams
- Have blood draws
- Answer questionnaires
- Have heart scans (ECG)
- Have photos taken of your skin
- Have skin biopsies
- Meet with the study team remotely or over the phone 3 times

During the study, we will let you know to avoid certain foods, supplements, herbs, and medications as they may interact with the study drug. You will be applying the study drug every day at least an hour before bedtime.

Study Details

Full Title
A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, STRATIFIED, VEHICLE-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF SIROLIMUS 3.9% TOPICAL GEL IN PREVENTION OF BCCS IN PATIENTS WITH GORLIN SYNDROME
Principal Investigator
Protocol Number
IRB: PRO00108852
NCT: NCT04893486
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698