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

Exclusion Criteria

• •1. Participants with basal cell nevus syndrome (BCNS, Gorlin syndrome, nevoid basal cell carcinoma syndrome; Online Mendelian Inheritance in Man \[OMIM\] #109400).
• •2. The participant has used topical products within 5 cm of a treatment- targeted BCC or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically, these include the use of:
• •1. Topical glucocorticoids 30 days prior to screening
• •2. Retinoids (such as etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically, or \> 5% of an alphahydroxy acid (such as glycolic acid, lactic acid), photodynamic therapy (PDT), or 5-fluorouracil or imiquimod (except as topical treatment to discrete BCCs) systemically or topically to the skin during the six months prior to entry.
• •3. Systemic chemotherapy within one year prior to screening. (Note: field therapy with topically applied treatments can be done as long as they are not applied within 5 cm of a treatment-targeted tumor).
• •4. Known inhibitors of the HH signaling pathway (such as vismodegib, patidegib, sonidegib, and itraconazole) topically or systemically within 6 months of entry into the study.
• •3. The participant has a history of hypersensitivity to any of the ingredients in the study medication formulation.
• •4. The participant is unable or unwilling to make a good faith effort to be present for all follow-up visits and tests.
• •5. The participant is a woman who is currently nursing.
• •6. The participant has any systemic disease that in the Investigator's opinion would interfere with the subject's ability to participate.
• •7. The participant has a clinically significant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis, that in the investigator's opinion would interfere with the participant's ability to participate.
• •8. The participant has any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the participant's participation in the study. This includes history of other skin conditions or diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of this investigational drug or that might affect interpretation of the results of the study or render the participant at high risk from treatment complications.
• •9. The participant has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of breast, or chronic lymphocytic lymphoma (CLL) (Stage 0).
• •10. The participant is currently participating in an experimental drug study (within 4 weeks of Baseline visit) or plans to participate in an experimental drug study while enrolled in this study.
• •11. The participant is on a concomitant medication that is a strong CYP3A4 inhibitor. These include, but are not limited to: larithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir.