Top-Line Results Show Day 57 Tumor Clearance With Investigational BCC Patch

Basal cell carcinoma (BCC) remains the most common malignancy worldwide, and although surgical excision continues to be the standard of care for most nodular lesions, interest in noninvasive or tissue-sparing approaches persists—particularly for patients with cosmetically sensitive lesions, multiple tumors, or limited surgical tolerance.¹ Noting this gap in the armamentarium, Medicus Pharma has reported top-line results from its phase 2 SKNJCT-003 study evaluating a dissolvable microneedle array (D-MNA) delivering doxorubicin for the treatment of nodular BCC.²

The randomized, double-blind, placebo-controlled, multicenter study enrolled 90 patients with nodular BCC and compared 2 dose levels—100 μg and 200 μg of doxorubicin delivered via microneedle patch—against a placebo MNA. Patients were randomly assigned in a 1:1:1 ratio.

Study Design and End Point

The primary end point was a composite, binary measure requiring both clinical (visual) clearance and histological clearance at a prespecified posttreatment time point. This dual requirement reflects an effort to align visible response with pathologic confirmation, a critical consideration in nonsurgical BCC management.

Patients were evaluated at either day 29 (n = 47) or day 57 (n = 43) following treatment. The split time points introduce some complexity when interpreting durability and timing of response, though the staggered assessment also offers insight into potential delayed effects.

Efficacy Findings

At day 29, response rates across groups were modest. In the placebo arm (n = 15), clinical clearance was observed in 33% and histological clearance in 20%. The 100 μg D-MNA group (n = 17) demonstrated 47% clinical clearance and 24% histological clearance, whereas the 200 μg cohort (n = 15) showed 40% clinical clearance and 27% histological clearance. By day 57, separation between groups became more apparent. In the placebo arm (n = 16), clinical clearance was 38% and histological clearance was 38%. The 100-μg group (n = 12) demonstrated 42% clinical clearance and 33% histological clearance. The 200-μg group (n = 15) showed 73% clinical clearance and 40% histological clearance.

The most notable signal was the 73% clinical clearance rate at day 57 in the 200-μg cohort, accompanied by 40% histological clearance. The data set suggests a time-dependent increase in response rates, particularly at the higher dose, consistent with ongoing local cytotoxic activity beyond the first month.

Interpreting the Placebo Response

One of the more intriguing aspects of the data set is the relatively high clearance rate observed in the placebo group, particularly the 38% histological clearance reported at day 57. Several factors could contribute, including sampling variability in small cohorts, mechanical effects of microneedle application, partial biopsy-related tumor debulking prior to enrollment, or spontaneous regression in selected lesions. Without detailed safety and procedural data—expected in the forthcoming clinical study report—interpretation remains provisional.

Clinical Context

For dermatologic oncologists and Mohs surgeons, the central question is not whether D-MNA can induce tumor regression, but whether response rates and durability will approach those of established surgical modalities.

The composite end point requiring histologic confirmation is a strength of the trial design. However, histological clearance rates at day 57 in the 200-μg group (40%) remain below what clinicians expect from excision or Mohs micrographic surgery. On the other hand, a noninvasive therapy with moderate complete response rates may still have a role in carefully selected patients, particularly those with multiple lesions or contraindications to surgery.

Importantly, SKNJCT-003 was not powered for registrational conclusions, and no regulatory determinations can be drawn at this stage. The company has indicated plans for an end-of-phase 2 meeting with the US FDA in the first half of 2026.

Broader Development Landscape

D-MNA builds on earlier phase 1 data (SKNJCT-001), which primarily demonstrated safety and tolerability, with some histologic complete responses reported. The current study represents the first randomized assessment of dose response.

Beyond SKNJCT-003, the company has initiated SKNJCT-004 in the United Arab Emirates and expanded regulatory approvals into the United Kingdom for SKNJCT-003. A collaboration with the Gorlin Syndrome Alliance aims to explore expanded access pathways for patients with nevoid BCC syndrome, a population that may particularly benefit from nonsurgical options.

Looking Ahead

Final safety analyses and procedural assessments are pending completion of the clinical study report, anticipated in Q2 2026. Long-term recurrence data, cosmetic outcomes, and patient-reported measures will be essential in defining the clinical niche of this therapy.

For now, SKNJCT-003 provides a signal of dose-dependent activity with evidence of increasing response over time at the 200-μg dose. Whether these findings translate into a competitive alternative—or a complementary tool for selected patients—will depend on durability, reproducibility in larger cohorts, and comparative performance against established standards of care.

Clinicians familiar with BCC management will watch closely as more complete data emerge.

References

1. Sutrisno CSN, Pramita DH, Dewi IP. Curative or conservative approaches: a systematic review of surgical and nonsurgical treatments for basal cell carcinoma. Cureus. 2025;17(10):e95556. doi:10.7759/cureus.95556
2. Medicus Pharma reports positive phase 2 SKNJCT-003 topline data observing 73% clinical clearance and 40% histological clearance (CR) at day 57 in 200μg cohort. News release. Medicus Pharma. March 5, 2026. Accessed March 5, 2026. https://medicuspharma.com/medicus-pharma-reports-positive-phase-2-sknjct-003-topline-data-observing-73-clinical-clearance-and-40-histological-clearance-cr-at-day-57-in-200g-cohort/