This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Patidegib Topical Gel, 2%
Incidence of Treatment-emergent Adverse Events (TEAEs)
IMP=Investigational medicinal product; Unique adverse event = adverse event of a certain preferred term, counted only once within each subject. Related adverse event = adverse event with relationship as Definitely, Probably or Possibly.
Time frame: 12 months
Change in Number of Facial BCCs Removed by Surgery
Time frame: 12 months
Change in Number of New Lesions Suspicious for BCC
Time frame: 12 months
Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score
Time frame: 12 months
Change in Dermatology Life Quality Index (DLQI)
Time frame: 12 months
Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)
Time frame: 12 months
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PellePharm Investigative Site
Fremont, California, United States
PellePharm Investigative Site
Newport Beach, California, United States
Yale University
New Haven, Connecticut, United States
Pellepharm Investigative Site
Miami, Florida, United States
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Ormond Beach, Florida, United States
PellePharm Investigative Site
Chicago, Illinois, United States
Laser & Skin Surgery Center of Indiana
Indianapolis, Indiana, United States
Pellepharm Investigative Site
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
...and 27 more locations