Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)

Inclusion Criteria

• Adult males and females, 40+ years in general good health as assessed by the investigator.
• BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit
• Primary BCC (i.e., no previous treatment)
• Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm
• Participant 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
• Negative urine pregnancy at study entry for female of child bearing potential
• Men and women of child-producing potential must agree to use adequate contraception according to standard instructions by the investigator until the completion of the study
• Participant must to be willing to adhere to the instructions of the investigator and his or her research team
• Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study

Exclusion Criteria

• Evidence of clinically significant, unstable medical conditions as assessed by the investigator
• Excisional biopsy 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 participant
• Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
• Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix
• Concomitant disease requiring systemic immunosuppressive treatment
• Genetic skin cancer disorder, e.g., basal cell nevus syndrome
• Participant is pregnant or breastfeeding
• Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit
• 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 elliptical excision