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Phase 2 Study Evaluating the Safety and Efficacy of Microneedle-mediated Delivery of Doxorubicin (D-MNA) in Patients With Nodular Basal Cell Carcinoma.
Sponsor: SkinJect, Inc.
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.
Official title: A Randomized, Double-blind, Three-arm Phase 2 Study Evaluating Two Dose Levels of Microneedle-mediated Delivery of Doxorubicin Compared With a Device-only Control in Patients With Nodular Basal Cell Carcinoma.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-09-03
Completion Date
2026-03-13
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
D-MNA 200µg
D-MNA, (doxorubicin) patch, 200µg
D-MNA 100µg
D-MNA (doxorubicin) patch, 100µg
Microneedle Array Alone
P-MNA patch, microneedle array alone
Locations (11)
Rao Dermotology West Coast -Site #4
Fresno, California, United States
Paradigm Research -Site #6
San Diego, California, United States
Therapeutics Clinical Research -site 08
San Diego, California, United States
Oak Dermotology - site 07
Naperville, Illinois, United States
Arlington Dermatology - Site #1
Rolling Meadows, Illinois, United States
Clinical Trials Management, LLC- Site #5
Mandeville, Louisiana, United States
Rao Dermatology - Site #3
Highlands, New Jersey, United States
HIckory Dermatology Research Center
Hickory, North Carolina, United States
American Skin and Cancer Center - Site#2
Knoxville, Tennessee, United States
Virginia Clinical Research Inc - site 11
Norfolk, Virginia, United States
Nottingham University Hospitals NHS Trust
Nottingham, East Midlands, United Kingdom