Northwest Arkansas Clinical Trials Center | Rogers, AR
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About
The aim of this clinical study is to find out how well Patidegib Gel 2% works in preventing new basal cell carcinomas (BCCs) developing on the face of adults with Gorlin syndrome, and how safe Patidegib Gel 2% is to use.
Participants will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between participants who used Patidegib Gel 2% or Vehicle Gel after 12 months.
Full description
This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Gel 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome.
Participants will be randomized (1:1) to receive either Patidegib Gel 2% or Vehicle Gel for 12 months. The assignment of participants to the 2 groups will be stratified by sex assigned at birth, age (≥60 or <60 years), and number of facial BCC lesions (10-15, 16-30 or >30) at baseline.
All BCCs at baseline, and any new BCCs which develop during the study, will be photographed and tracked during the study. New BCCs will be confirmed by dermoscopy analysis.
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Primary purpose
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Interventional model
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140 participants in 2 patient groups, including a placebo group
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Patient Referral Support Service
Data sourced from clinicaltrials.gov
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