Status:
COMPLETED
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
Lead Sponsor:
Palvella Therapeutics, Inc.
Conditions:
BCCs in Gorlin Syndrome Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wher...
Eligibility Criteria
Inclusion
- Key
- Adults, 18 years or older
- 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
- Key
Exclusion
- Recently participated in a clinical trial evaluating an investigational product for the treatment of BCCs or Gorlin Syndrome within 3 months prior to to starting study medication. Participant can start the study screening period prior to completing the 3 month washout.
- Recently used topical or systemic (oral) treatment that might interfere with the evaluation of the study medication.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04893486
Start Date
May 6 2021
End Date
March 13 2023
Last Update
August 29 2024
Active Locations (16)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Burke Pharmaceuticals Research
Hot Springs, Arkansas, United States, 71913
3
Stanford Univeristy
Palo Alto, California, United States, 94304
4
Park Avenue Dermatology
Orange Park, Florida, United States, 32073