Overview
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
Description
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.
Eligibility
Inclusion Criteria:
- Male or non-pregnant female ≥ 18 years of age.
- Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline.
- Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning beds for the duration of the study.
- Willing and able to receive the test article treatments, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Exclusion Criteria:
- Pregnant, lactating, or planning to become pregnant.
- nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
- History of treated nBCC lesion recurrence or basal cell nevus syndrome.
- Immunocompromised, based on medical condition (e.g., human immunodeficiency virus), medication use, or other factors.
- Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
- Used systemic chemotherapeutic agents within the 12 months prior to Visit 2/Baseline.
- Clinical laboratory results at Visit 1/Screening within the following ranges: (a) granulocytes < 2,000/mm3, (b) platelets <50,000/mm3, (c) serum creatinine greater than 2 times the upper limit of normal (ULN), (d) aspartate aminotransferase, alkaline aminotransferase, lactate dehydrogenase, or alkaline phosphatase greater than 3 times the ULN.
- History of sensitivity to any of the ingredients in the test articles .
- Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
- Used the following topical agents within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinic acid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.
- Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm of the Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
- Currently enrolled in an investigational drug, biologic, or device study. 12. Used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to enrollment into the study.
- Unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity)