NCT04928222

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

A Trial to Evaluate Placebo Microneedle Arrays in Healthy Human Volunteers (Part I), Followed by Proof of Concept Testing of Efficacy and Safety of Doxorubicin Microneedle Arrays in Subjects With Basal Cell Cancer (Part II)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: SkinJect, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Doxorubicin-containing MNA	A 15 x 15 millimeter array containing 400 dissolvable microneedles delivering active agent
DRUG	Placebo-containing MNA	A 15 15 x 15 millimeter array containing 400 dissolvable microneedles containing placebo

Timeline

• Start date: 2021-09-24
• Primary completion: 2023-12-30
• Completion: 2024-06-30
• First posted: 2021-06-16
• Last updated: 2023-04-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study