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

Inclusion criteria

• Adult males and females, 18+ years in general good health as assessed by the investigator.
• Clinical laboratory results within the following ranges:

• granulocytes ≥2,000/mm3
• platelets >50,000/mm3
• serum creatinine ≤2X the upper limit of normal (ULN)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), alkaline phosphatase ≤3X the ULN.
• 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.
• Subject must be willing to adhere to the instructions of the investigator and his or her research team.
• Subject must sign an Informed Consent Form prior to any study specific procedures and entry into the study.
• 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.
• Biopsy removed ≤25% of the original volume of the target lesion.
• Primary BCC (i.e., no previous treatment)
• 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
• Subjects must avoid sunlight/ultraviolet light to the target lesion for the duration of the study.
• Female subjects must be:

• postmenopausal (no menstrual period for a minimum of 12 months), or
• surgically sterile upon entry into the study.
• 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
• 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.

Exclusion criteria

• Evidence of clinically significant, unstable medical conditions as assessed by the investigator.
• Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
• Female subjects who are pregnant or breastfeeding.
• The subject has uncontrolled, significant intercurrent or recent illness.
• Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g. dabigatran), betrixaban, or platelet inhibitors (eg, clopidogrel). Prophylactic use of Low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH) are permitted.
• Topical therapy(ies) to the target lesion within 6 weeks of first treatment.
• Prior excisional surgery performed on the lesion to be treated in this study.
• Recent therapy(ies) to the BCC treatment area.
• Recurrent BCC (previously treated) at the site presented for treatment.
• BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the subject
• Subject with other active malignancies except for non-metastatic prostate cancer, carcinoma in situ of the skin or cervix, and basal cell cancer in locations other than lesion of interest.
• Subject with evidence of metastatic malignancies.
• Concomitant disease requiring systemic immunosuppressive treatment.
• Genetic skin cancer disorder, e.g., basal cell nevus syndrome.
• Subject is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment (patients who are in a follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent).
• Evidence of dermatological disease or confounding skin condition within 3 mm margin of the target BCC lesion, e.g., SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema.
• Existing condition or treatment within 3 months prior to the Screening Visit that may have impact on clinical outcome for the treatment of BCC or delay in wound healing from the standard of care excision.