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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04928222
Study type Interventional
Source SkinJect, Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 24, 2021
Completion date June 30, 2024

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