drugset / Trial / NCT06608238

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

NCT06608238 ↗

Phase 2 Completed 90 enrolled SkinJect, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2024-09-03
Primary completion
2026-03-05
Completion
2026-03-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 100 ug Other
Comparator Doxorubicin Other / unclassified 200 ug Other