Phase
Condition
Basal Cell Carcinoma
Carcinoma
Treatment
D-MNA 100 mcg
Placebo
D-MNA 200 mcg
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or non-pregnant female ≥ 18 years of age.
Clinical diagnosis of a primary, previously untreated, histologically confirmednodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of thestudy) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3cm at the time of biopsy and Visit 2/Baseline.
Willing to refrain from exposure to excessive direct sunlight or ultraviolet lightand to avoid the use of tanning beds for the duration of the study.
Willing and able to receive the test article treatments, comply with studyinstructions, and commit to all follow-up visits for the duration of the study.
Exclusion
Exclusion Criteria:
Pregnant, lactating, or planning to become pregnant.
nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred orpreviously 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 basalor 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) serumcreatinine greater than 2 times the upper limit of normal (ULN), (d) aspartateaminotransferase, alkaline aminotransferase, lactate dehydrogenase, or alkalinephosphatase 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 weeksprior to Visit 2/Baseline or after the confirmatory biopsy.
Used the following topical agents within 2 cm of the Target Lesion within the 4weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinicacid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.
Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm ofthe Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatorybiopsy.
Currently enrolled in an investigational drug, biologic, or device study. 12. Usedan investigational drug, investigational biologic, or investigational devicetreatment within 30 days prior to enrollment into the study.
Unlikely to comply with the requirements of the study protocol (e.g., due toalcoholism, drug dependency, mental incapacity)
Study Design
Study Description
Connect with a study center
Site #4
Fresno, California 93720
United StatesActive - Recruiting
Site #6
San Diego, California 92108
United StatesSite Not Available
Site #1
Rolling Meadows, Illinois 60008
United StatesActive - Recruiting
Site #5
Mandeville, Louisiana 70448
United StatesActive - Recruiting
Site #3
Highlands, New Jersey 07716
United StatesActive - Recruiting
Site#2
Knoxville, Tennessee 37909
United StatesActive - Recruiting

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