The goal of the study is to investigate the safety and effectivness of the microneedle array alone and in combination with two different doses of doxorubibin (100ug and 200ug) in the treatment of nodular basal cell skin cancer.
About 60 subjects will be enrolled. Enrolled subjects will be randomly allocated to receive D-MNA or MNA alone on the identified target lesion once weekly for 3 weeks. After two weeks, the target lesion will be excised. An Interim Analysis will be done after 26-30 subjects would have completed Visit 5/ Excision Visit. After approximately one half of the subjects were enrolled, the protocol was ammended to enroll a total of 90 patients 1:1:1 and to change the excisional biopsy day from day 29 to day 57; approximately 6 weeks after the last microneedle array application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
D-MNA , (doxorubicin) patch, 200 mcg
D-MNA (doxorubicin) patch, 100 mcg
P-MNA patch, microneed array alone
Rao Dermotology West Coast -Site #4
Fresno, California, United States
Paradigm Research -Site #6
San Diego, California, United States
Therapeutics Clinical Research -site 08
San Diego, California, United States
Histological Clearance of Target Lesion
Proportion of subjects with complete histological clearance of the Target Lesion at Visit 5/EV
Time frame: 29 or 57 days from enrollment into the study
Clinical Clearance of Target Lesion
Proportion of subjects with complete clinical clearance of the Target Lesion at Visit 5/EV.
Time frame: 29 or 57 days from enrollment into the study
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