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
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    60
  • sponsor
    Palvella Therapeutics, Inc.
Updated on 21 September 2022

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.

Details
Condition BCCs in Gorlin Syndrome Patients
Treatment PTX-022, Vehicle comparator
Clinical Study IdentifierNCT04893486
SponsorPalvella Therapeutics, Inc.
Last Modified on21 September 2022

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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