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
NCT ID: NCT04893486
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2021-05-06
2023-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active
PTX-022
QTORIN 3.9 % Sirolimus Topical Gel
Vehicle
Vehicle comparator
Vehicle comparator topical gel
Interventions
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PTX-022
QTORIN 3.9 % Sirolimus Topical Gel
Vehicle comparator
Vehicle comparator topical gel
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Recently used topical or systemic (oral) treatment that might interfere with the evaluation of the study medication.
18 Years
ALL
No
Sponsors
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Palvella Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Bickers, MD
Role: STUDY_CHAIR
Columbia University
Joyce Teng, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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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
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
Countries
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Related Links
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Sign-up to be contacted about participation in the clinical trial
Gorlin Syndrome Alliance
Other Identifiers
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PALV-04
Identifier Type: -
Identifier Source: org_study_id
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