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CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome
Recruiting
Trial ID: NCT04893486
Purpose
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.
Official Title
A Multicenter, Phase 2B, Randomized, Double-Blind, Stratified, Vehicle-Controlled Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel In Prevention Of BCCs In Patients With Gorlin Syndrome
Stanford Investigator(s)
Joyce Teng, MD, PhD
Professor of Dermatology and, by courtesy, of Pediatrics
Eligibility
Key Inclusion Criteria:
- Adults, 18 years or older
- Meet diagnostic criteria for Gorlin Syndrome
- Willing to avoid application of a non-study topical medication to the face
(prescription or over the counter) during the study.
- Willing to forego treatment of BCCs with anything other than the study medication
except when the Investigator believes that delay of treatment of a BCC potentially
might compromise the health of the subject. During the trial, the only allowed form of
BCC treatment is surgical.
- Participant will be encouraged to use their preferred sunscreen with a sun protector
factor (SPF) of at least 30 daily
Key Exclusion Criteria:
- Recently participated in a clinical trial evaluating an investigational product for
the treatment of BCCs or Gorlin Syndrome within 3 months prior to to starting study
medication. Participant can start the study screening period prior to completing the 3
month washout.
- Recently used topical or systemic (oral) treatment that might interfere with the
evaluation of the study medication.
Intervention(s):
drug: PTX-022
drug: Vehicle comparator
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305