D-MNA for Basal Cell Carcinoma

This trial tests a new treatment called D-MNA (Doxorubicin Micro-Array) for nodular basal cell carcinoma, a common type of skin cancer. The study aims to determine the safety and effectiveness of two different doses of D-MNA compared to a placebo (a harmless look-alike patch). Participants will receive either the D-MNA patch or a placebo patch once a week for two weeks. Individuals with a confirmed diagnosis of untreated nodular basal cell carcinoma, not located on the face or other excluded areas, might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective new treatment.

The trial does not specify if you need to stop taking your current medications, but you cannot have used systemic chemotherapeutic agents in the past 12 months or certain topical agents near the target lesion in the past 4 weeks.

Research shows that D-MNA, a new treatment being tested for basal cell carcinoma, is generally safe. Earlier studies found D-MNA to be safe and showed early signs of effectiveness against skin cancer. Participants in one study tolerated D-MNA well at various doses, with no serious side effects reported. Even at higher doses, D-MNA did not cause major harmful effects. These results suggest that D-MNA is well-tolerated and could be a safe option for those considering joining a clinical trial.¹²³⁴⁵

Researchers are excited about these treatments because D-MNA introduces a unique approach to treating basal cell carcinoma with an innovative delivery method. Unlike traditional treatments that typically involve surgical removal or topical therapies, D-MNA uses an intradermal patch, which is less invasive and potentially more convenient for patients. The treatment features a microneedle array that delivers the active ingredient directly into the skin, which could enhance the precision and effectiveness of the medication. Additionally, the treatment is administered in just two weekly sessions, offering a quicker regimen compared to many existing options.

Research has shown that D-MNA is a promising treatment for basal cell carcinoma, a common type of skin cancer. In earlier studies, over 60% of patients experienced complete disappearance of their cancer, meaning it was no longer detectable. Importantly, these studies found no serious side effects, indicating the treatment was safe at the doses tested. In this trial, participants will receive either a 100 mcg or 200 mcg dose of D-MNA via a microneedle patch, or a placebo patch. D-MNA uses a microneedle patch to deliver the drug doxorubicin directly to the cancer site, enhancing penetration compared to creams. This targeted delivery might explain its superior performance over some other treatments. Overall, these findings suggest that D-MNA could be an effective and safe option for treating basal cell carcinoma.¹⁴⁵⁶⁷