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Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
EU CTIS ID: 2023-507528-21-00
What this study is testing
To assess the efficacy of Patidegib Gel 2% in subjects with Gorlin syndrome
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject must be at least 18 years old at the Screening Visit
- The subject must be confirmed to have a PTCH1 mutation
- The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1)
- The subject must be willing to abstain from application of any non-study topical medication (prescription or over the counter) to their facial skin for the duration of the trial, except as prescribed by the investigator
You likely can't join if
- The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP)
- The subject is known to have hypersensitivity to any of the ingredients in the IP formulation
- The subject has uncontrolled systemic disease
- The subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia Stage 0 and non-melanoma skin cancer, Stage I cervical cancer, or ductal carcinoma in situ of the breast
- Previous Hedgehog inhibitor therapy was considered to have failed for reasons other than unfavorable side effect(s)
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.