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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04893486

Public ClinicalTrials.gov record NCT04893486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:49 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04893486
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Palvella Therapeutics, Inc.
Industry
Enrollment
73 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 5, 2021
Primary completion
Mar 12, 2023
Completion
Mar 12, 2023
Last update posted
Aug 28, 2024

2021 – 2023

United States locations

U.S. sites
14
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Mayo Clinic Scottsdale Arizona 85259
Burke Pharmaceuticals Research Hot Springs Arkansas 71913
Stanford Univeristy Palo Alto California 94304
Park Avenue Dermatology Orange Park Florida 32073
Ameriderm Research Ormond Beach Florida 32174
Gwinett Clinical Research Center Snellville Georgia 30078
Clinical Coordinating Center (Minnesota) New Brighton Minnesota 55112
Mayo Clinic - Minnesota Rochester Minnesota 55905
St. Louis University St Louis Missouri 63110
Duke University Durham North Carolina 27705
Penn State Hershey Medical Center Hershey Pennsylvania 17033
DermResearch Inc Austin Texas 78759
University of Utah Murray Utah 84107
Virginia Clinical Research, Inc. Norfolk Virginia 23502

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04893486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 28, 2024 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04893486 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →