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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.

NCT06608238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Nodular Basal Cell Carcinoma

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

Sponsors & Collaborators

  • SkinJect, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2026-03-05
Completion
2026-03-13
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06608238 on ClinicalTrials.gov