Phase 2 Study Evaluating the Safety and Efficacy of Microneedle-mediated Delivery of Doxorubicin (D-MNA) in Patients With Nodular Basal Cell Carcinoma.

Overview

This Phase 2 study evaluates the safety and efficacy of microneedle array (MNA) alone and in combination with two dose levels of doxorubicin (100µg and 200µg) in patients with nodular basal cell carcinoma. Efficacy is assessed using both clinical (visual) and histological endpoints, which together provide a comprehensive evaluation of lesion response.

A total of 90 subjects were enrolled and randomized in a 1:1:1 ratio to receive microneedle array (MNA) alone or Doxorubicin-MNA (D-MNA) at dose levels of 100µg or 200µg. Treatments were administered once weekly for three applications to a single target lesion. Following treatment, the target lesion was excised at a prespecified timepoint and assessed for clearance. The study was amended during conduct to increase the total sample size (from 60 to 90) and to extend the timing of excision from Day 29 to Day 57 to allow for an optimized evaluation for treatment response. Efficacy is evaluated using both clinical (visual) and histological assessments. These endpoints represent complementary dimensions of lesion response, with clinical clearance reflecting visible resolution and histological clearance providing pathological confirmation. Central pathological review was conducted for all excision specimens and where possible, baseline biopsy visits to confirm nodular BCC. This Phase 2 study is exploratory in nature, and efficacy is interpreted based on the totality of evidence across endpoints rather than a strictly hierarchical framework. Analyses are descriptive and not powered for formal hypothesis testing.

Conditions

Interventions

Eligibility

Locations (11)

Outcomes