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COMPLETED
NCT06608238
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

D-MNA 200µg

D-MNA, (doxorubicin) patch, 200µg

DRUG

D-MNA 100µg

D-MNA (doxorubicin) patch, 100µg

OTHER

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