The Purpose of This Study is to Evaluate the Safety and Efficacy of D-MNA in Adult Patients With Nodular Basal Cell Carcinoma

Launched by SKINJECT, INC. · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called D-MNA for adults with a type of skin cancer known as nodular basal cell carcinoma (nBCC). The study aims to find out how safe and effective two different strengths of D-MNA are compared to a placebo, which is a substance that doesn’t contain any active medication. Participants will be adults aged 18 and older who have a specific type of nBCC that has not been treated before and meets certain size criteria. They will need to commit to following study instructions and attending all follow-up visits.

If you or a loved one is considering participating, it’s important to know that there are some eligibility requirements, such as not being pregnant or planning to become pregnant, and not having certain health conditions that could interfere with the study. Participants will be asked to avoid excessive sun exposure and will receive treatments over the course of the study. This trial is currently recruiting participants, and it could be an opportunity to help researchers learn more about potential new options for treating this type of skin cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or non-pregnant female ≥ 18 years of age.
• • 2. 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.
• • 3. 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.
• • 4. 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:
• • 1. Pregnant, lactating, or planning to become pregnant.
• • 2. nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
• • 3. History of treated nBCC lesion recurrence or basal cell nevus syndrome.
• • 4. Immunocompromised, based on medical condition (e.g., human immunodeficiency virus), medication use, or other factors.
• • 5. Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
• • 6. Used systemic chemotherapeutic agents within the 12 months prior to Visit 2/Baseline.
• • 7. 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.
• • 8. History of sensitivity to any of the ingredients in the test articles .
• • 12. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
• • 9. 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.
• • 10. 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.
• • 11. 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.
• • 13. Unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity)