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Brief Title: 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
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
Study ID: NCT04893486
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint Louis, Missouri, United States
Duke University, Durham, North Carolina, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
DermResearch Inc, Austin, Texas, United States
University of Utah, Murray, Utah, United States
Virginia Clinical Research, Inc., Norfolk, Virginia, United States
St. Pancras Clinical Research, London, , United Kingdom
Salford Foundation Trust, Salford, , United Kingdom
Name: David Bickers, MD
Affiliation: Columbia University
Role: STUDY_CHAIR
Name: Joyce Teng, MD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR