NCT04893486

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Palvella Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BCCs in Gorlin Syndrome Patients

Interventions

Type	Name	Description
DRUG	PTX-022	QTORIN 3.9 % Sirolimus Topical Gel
DRUG	Vehicle comparator	Vehicle comparator topical gel

Timeline

• Start date: 2021-05-06
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2021-05-19
• Last updated: 2024-08-29

Locations

16 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study