Basal Cell Carcinomas Clinical Trial
Official title:
A Placebo Controlled Double-Blind Study to Evaluate the Efficacy of Vismodegib as Chemoprevention of New Bcc Development in High Risk Subjects
This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).
The primary objective of this study will be to determine if vismodegib pulse therapy will
significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high
risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed
BCC over a 24 month period.
The secondary objective will be to determine that there will be no difference in the
incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving
vismodegib treatment when compared with placebo, as measured by the incidence of biopsy
confirmed SCC over the same 24 month period.
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