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NCT04893486 · ClinicalTrials.gov registry record · Phase 2
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 2 study, sponsored by Palvella Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT04893486 is a Phase 2 study that has completed, run by Palvella Therapeutics. The registered enrollment target is 73 participants.
The verdict
NCT04893486, a Phase 2 study, has completed, sponsored by Palvella Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study 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.
Interventions
- DRUG PTX-022
- DRUG Vehicle comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2023-03-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04893486
The ClinicalTrials.gov registry entry for NCT04893486 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Palvella Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PTX-022 is the first listed.
NCT04893486 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04893486 about?
NCT04893486 is a clinical study titled "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 place...
What is the current status of trial NCT04893486?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2021-05-06. Estimated completion is 2023-03-13.
What interventions are being tested in trial NCT04893486?
The interventions under investigation include: PTX-022 (DRUG), Vehicle comparator (DRUG).
Who is sponsoring clinical trial NCT04893486?
This trial is sponsored by Palvella Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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