Microneedle Chemotherapy for Skin Cancer

(cSCC Trial)

This trial tests a new method for treating cutaneous squamous cell carcinoma (a type of skin cancer) using small patches with tiny needles. These patches deliver low doses of doxorubicin, a chemotherapy drug, directly to the cancerous area. The trial aims to determine the safety and effectiveness of this method. Individuals with a biopsy-confirmed diagnosis of resectable stage I-III cSCC who can follow study instructions might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other investigational treatments. You also cannot receive other treatments for skin cancer, except for certain skin moisturizers without steroids or antibiotics.

Research has shown that the microneedle array doxorubicin (MNA-D) patch was well-tolerated in past studies. Researchers identified 50 micrograms as the highest safe dose for another type of skin cancer. This indicates that the patches are generally safe, with careful monitoring of the application site. Other studies have also demonstrated positive results in using these patches to deliver chemotherapy drugs like doxorubicin. This method allows for targeted and controlled release, which can help reduce side effects. Overall, the MNA-D patches appear to be a safe option for those considering participation in this clinical trial.¹²³⁴⁵

Unlike the standard treatments for skin cancer, which often involve surgical removal, radiation, or topical chemotherapy creams, the Microneedle Chemotherapy uses a microneedle array to deliver doxorubicin directly into the skin. This method is unique because it precisely targets cancer cells with minimal discomfort, reducing side effects associated with traditional chemotherapy. Researchers are excited about this approach because it potentially offers a less invasive and more localized treatment option, which could be particularly beneficial for patients with compromised immune systems.

Studies have shown that microneedle patches containing doxorubicin can improve treatment for skin cancers like basal cell carcinoma. In this trial, participants will receive the Microneedle Array Doxorubicin (MNA-D) patch, which targets cancer more precisely than standard creams. This allows the medication to penetrate deeper into the skin and potentially enhance effectiveness. Early research using similar microneedle technology for other skin cancers has shown promising results, indicating it might also be effective for cutaneous squamous cell carcinoma (cSCC). The microneedle patches are designed to dissolve, releasing the drug slowly over time, which may reduce side effects compared to traditional chemotherapy. These encouraging findings suggest that this new method could offer a more effective and targeted way to treat skin cancer.¹²³⁵⁶