NCT06608238

The Purpose of This Study is to Evaluate the Safety and Efficacy of D-MNA in Adult Patients With Nodular Basal Cell Carcinoma

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: SkinJect, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of the study is to investigate the safety and effectivness of the microneedle array alone and in combination with two different doses of doxorubibin (100ug and 200ug) in the treatment of nodular basal cell skin cancer.

Detailed description

About 60 subjects will be enrolled. Enrolled subjects will be randomly allocated to receive D-MNA or MNA alone on the identified target lesion once weekly for 3 weeks. After two weeks, the target lesion will be excised. An Interim Analysis will be done after 26-30 subjects would have completed Visit 5/ Excision Visit. After approximately one half of the subjects were enrolled, the protocol was ammended to enroll a total of 90 patients 1:1:1 and to change the excisional biopsy day from day 29 to day 57; approximately 6 weeks after the last microneedle array application.

Conditions

• Nodular Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	D-MNA 200 mcg	D-MNA , (doxorubicin) patch, 200 mcg
DRUG	D-MNA 100 mcg	D-MNA (doxorubicin) patch, 100 mcg
OTHER	microneedle array alone	P-MNA patch, microneed array alone

Timeline

• Start date: 2024-09-03
• Primary completion: 2026-03-05
• Completion: 2026-03-13
• First posted: 2024-09-23
• Last updated: 2026-04-02

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study