Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)

Inclusion Criteria

• •1. Adult males and females, 18+ years in general good health as assessed by the investigator.
• •2. Clinical laboratory results within the following ranges:
• •1. granulocytes ≥2,000/mm3
• •2. platelets \>50,000/mm3
• •3. serum creatinine ≤2X the upper limit of normal (ULN)
• •4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), alkaline phosphatase ≤3X the ULN.
• •3. Subject must have no other "clinically significant" abnormal findings in his/her medical history, physical examination or clinical laboratory test results as assessed by the investigator.
• •4. Subject must be willing to adhere to the instructions of the investigator and his or her research team.
• •5. Subject must sign an Informed Consent Form prior to any study specific procedures and entry into the study.
• •6. BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit. If previously confirmed, subjects can only have diagnosed BCC via shaved biopsy within 6 months of first study treatment.
• •7. Biopsy removed ≤25% of the original volume of the target lesion.
• •8. Primary BCC (i.e., no previous treatment)
• •9. Lesion size ≥ 64 mm2 or 8 x 8 mm and ≤ 169 mm2 or 13 x 13 mm, i.e., the entire lesion must be covered by 13X13 mm area of the array containing the microneedles
• •10. Subjects must avoid sunlight/ultraviolet light to the target lesion for the duration of the study.
• •11. Female subjects must be:
• •1. postmenopausal (no menstrual period for a minimum of 12 months), or
• •2. surgically sterile upon entry into the study.
• •3. female subjects of childbearing potential must have a negative pregnancy test upon entry into this study and agree to use a highly effective method of contraception from Screening until the final follow-up visit. Consult Section 5.5 in this protocol for a description of effective contraceptive methods. Female subjects must also have negative pregnancy tests before each dose is applied to female subjects
• •12. Male subjects with female partners of child bearing potential must be either surgically sterile or agree to use a double-barrier contraception method (i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam) from screening until the final follow-up visit.