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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 Oct 22, 2026, 3:36 AM 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 6, 2021 (Actual)
Primary completion
Mar 13, 2023 (Actual)
Completion
Mar 13, 2023 (Actual)
Last update posted
Aug 29, 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 29, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04893486 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →