A new microneedle-based treatment for nodular basal cell carcinoma has demonstrated an 80% overall response rate in clinical trials, potentially offering thousands of skin cancer patients a less invasive alternative to surgery. The SkinJect system, which uses a patch of tiny needles to deliver the chemotherapy drug doxorubicin directly into skin lesions, showed that approximately 73% of treated lesions achieved visible clearance by day 57 in the phase 2 SKNJCT-003 trial .

What Exactly Is This Microneedle Technology and How Does It Work?

The SkinJect system represents a fundamentally different approach to treating basal cell carcinoma, one of the most common types of skin cancer. Rather than surgically removing the lesion, the microneedle array creates a pathway for doxorubicin, a chemotherapy medication, to penetrate directly into the cancerous tissue. The device itself is biologically active, meaning it provides therapeutic benefit even without the drug, but the combination of the microneedles and doxorubicin creates a significantly stronger treatment effect .

In the SKNJCT-003 trial, 90 patients were randomly assigned to receive either 200 micrograms of doxorubicin, 100 micrograms of doxorubicin, or a placebo device. The results clearly separated the active treatment from the control. At day 57, the 200-microgram dose achieved a 73% clinical clearance rate, meaning nearly three-quarters of treated lesions showed visible tumor clearance, and a 40% histological clearance rate, indicating complete elimination of cancer cells under microscopic examination .

"The clear separation between active drug and device-only control demonstrates a clinically meaningful therapeutic effect on top of a biologically active platform. Approximately 3 out of 4 treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention," stated Babar Rao, MD, FAAD, professor of Dermatology and Pathology and director of Clinical Research at Rutgers Robert Wood Johnson Medical School.

Babar Rao, MD, FAAD, Professor of Dermatology and Pathology at Rutgers Robert Wood Johnson Medical School

Who Could Benefit Most From This New Treatment Option?

The SkinJect system is being positioned as a non-surgical alternative for specific patient populations who might struggle with traditional Mohs surgery, which is the gold standard for basal cell carcinoma removal. This includes patients with limited access to specialized surgical centers, those who prefer less invasive treatment options, and individuals with multiple lesions requiring treatment .

The trial enrolled patients aged 18 and older with previously untreated nodular basal cell carcinoma lesions that were suitable for surgical removal. Patients had to be willing to avoid direct sunlight and ultraviolet light exposure during treatment and commit to follow-up visits. The study excluded pregnant or lactating women, patients with a history of nevoid basal cell carcinoma (a genetic condition causing multiple skin cancers), and immunocompromised individuals .

How to Determine If Microneedle Treatment Might Be Right for You

• Lesion Type: The treatment is specifically designed for nodular basal cell carcinoma, the most common subtype of basal cell carcinoma, which typically appears as a firm, pearly bump on the skin.
• Treatment History: Patients must have a primary, previously untreated lesion, meaning the cancer has not been treated before with other therapies.
• Accessibility Considerations: If you live far from a dermatologic surgery center, have mobility limitations, or prefer to avoid surgical procedures, this non-invasive option may be particularly appealing.
• Multiple Lesions: Patients with several basal cell carcinomas may benefit from a treatment that can address multiple lesions without requiring separate surgical procedures.

The trial data showed measurable differences between dose levels. At day 29, the 200-microgram cohort achieved a 40% clinical clearance rate and 27% histological clearance rate. The 100-microgram cohort showed a 47% clinical clearance rate and 24% histological clearance rate, while placebo recipients had 33% and 20% clearance rates respectively . These results suggest that the 200-microgram dose provides the optimal balance of efficacy and safety, which is why developers have selected it as the lead dose for further development.

What's Next for This Treatment?

The positive phase 2 results have opened the door to regulatory discussions with the FDA. Medicus Pharma, the company developing SkinJect, held a Type C meeting with the FDA to discuss the clinical pathway for doxorubicin microneedle array treatment in patients with superficial or nodular basal cell carcinoma. This type of meeting allows regulatory authorities and drug developers to align on the evidence needed for potential approval .

The independent clinical validation of the SkinJect dataset was deemed clinically meaningful, supporting continued development and regulatory engagement. For patients currently dealing with basal cell carcinoma, this represents a significant step toward having more treatment options available. While surgery remains the standard approach, having a non-invasive alternative could transform care for patients who face barriers to surgical treatment or simply prefer a less invasive approach to managing their skin cancer.