drugset / Trial / NCT02828111

Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas

NCT02828111

Phase 2 Completed 36 enrolled PellePharm, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in comparison with that of vehicle in patients with Basal Cell Carcinoma. One investigational center (metasite) in the United States will participate in this study. Approximately 36 subjects who meet the study entry criteria will be enrolled into one of four sequential cohorts. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or vehicle gel.

Timeline

Start
2016-11-11
Primary completion
2017-11-09
Completion
2017-11-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Patidegib Small molecule 2 % Topical
Subject Patidegib Small molecule 4 % Topical

Indications