Neoplasms

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Musculoskeletal Diseases

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Syndrome

Carcinoma, Basal Cell

Basal Cell Nevus Syndrome

Nevus, Pigmented

Nevus

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

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Nevoid Basal Cell Carcinoma Syndrome

Anti-Infective Agents

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Sirolimus

PTX-022

Vehicle comparator

Kathy Goin

Study Coordinator

Tim Dugan

Elidia Tafoya

Dea Kemlage

Sandra Warrington

Colleen Ethridge

Patient Navigator

Addison Demer

Rhonda Lebbing

Connor Whatley

Karina Garcia

Sean Wetland

Erin Rivera

Stuart Ratcliff, MD

David Bickers, MD

Joyce Teng, MD

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.

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

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

Palvella Therapeutics, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT04893486	BCCs in Gorlin ...	PTX-022 Vehicle compara...	18 Years -	Palvella Therapeutics, Inc.
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	NCT04893486	BCCs in Gorlin ...	PTX-022 Vehicle compara...	18 Years -	Palvella Therapeutics, Inc.

Spots Global Cancer Trial Database for gorlin syndrome alliance