The goal of the study is to learn about the safety and how effective two different strengths of D-MNA compared to a placebo (a look-alike substance that contains no drug) in the treatment of nodular basal cell skin cancer
A double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of D-MNA which is administered as an intradermal injection in subjects with nodular Basal Cell Carcinoma (nBCC). About 60 subjects will be enrolled. Enrolled subjects will be randomly allocated to receive D-MNA or placebo injection 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
D-MNA , (doxorubicin) patch, 200 mcg
D-MNA (doxorubicin) patch, 100 mcg
P-MNA patch, placebo
Site #4
Fresno, California, United States
RECRUITINGSite #6
San Diego, California, United States
NOT_YET_RECRUITINGSite #1
Rolling Meadows, Illinois, United States
RECRUITINGHistological Clearance of Target Lesion
Proportion of subjects with complete histological clearance of the Target Lesion at Visit 5/EV
Time frame: 29 to 34 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 to 34 days from enrollment into the study
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Site #5
Mandeville, Louisiana, United States
RECRUITINGSite #3
Highlands, New Jersey, United States
RECRUITINGSite#2
Knoxville, Tennessee, United States
RECRUITING