| Eligibility |
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.
Exclusion Criteria:
1. Evidence of clinically significant, unstable medical conditions as assessed by the
investigator.
2. Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
3. Female subjects who are pregnant or breastfeeding.
4. The subject has uncontrolled, significant intercurrent or recent illness.
5. 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.
6. Topical therapy(ies) to the target lesion within 6 weeks of first treatment.
7. Prior excisional surgery performed on the lesion to be treated in this study.
8. Recent therapy(ies) to the BCC treatment area.
9. Recurrent BCC (previously treated) at the site presented for treatment.
10. BCC lesion to be treated is located in an area where excisional biopsy is undesired or
aesthetically unacceptable to the subject
11. 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.
12. Subject with evidence of metastatic malignancies.
13. Concomitant disease requiring systemic immunosuppressive treatment.
14. Genetic skin cancer disorder, e.g., basal cell nevus syndrome.
15. 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).
16. 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.
17. 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.
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