Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)

Summary

Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic location; age; duration of array exposure to the skin; and the criticality of proper array application to the skin. Part II will be a randomized study in which doxorubicin-containing arrays will be applied to subjects demonstrated by biopsy to have basal cell cancer. A subject will be randomized to one of four dose groups: placebo microneedle array and 50 µg, 100 µg, and 200 µg doses of doxorubicin in a tip-loaded, dissolvable microneedle arrays (D-MNA).

Timeline

Start

2021-09-24

Primary completion

2023-12-30

Completion

2024-06-30

Drugs

Indications