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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 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.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: PTX-022
  • drug: Vehicle comparator

Eligibility


Key Inclusion Criteria:

   - 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 Criteria:

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting