Phase 2 Study Evaluating the Safety and Efficacy of Microneedle-mediated Delivery of Doxorubicin (D-MNA) in Patients With Nodular Basal Cell Carcinoma.

April 28, 2026 updated by: SkinJect, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 90 subjects were enrolled and randomized in a 1:1:1 ratio to receive microneedle array (MNA) alone or Doxorubicin-MNA (D-MNA) at dose levels of 100µg or 200µg. Treatments were administered once weekly for three applications to a single target lesion. Following treatment, the target lesion was excised at a prespecified timepoint and assessed for clearance. The study was amended during conduct to increase the total sample size (from 60 to 90) and to extend the timing of excision from Day 29 to Day 57 to allow for an optimized evaluation for treatment response. Efficacy is evaluated using both clinical (visual) and histological assessments. These endpoints represent complementary dimensions of lesion response, with clinical clearance reflecting visible resolution and histological clearance providing pathological confirmation. Central pathological review was conducted for all excision specimens and where possible, baseline biopsy visits to confirm nodular BCC. This Phase 2 study is exploratory in nature, and efficacy is interpreted based on the totality of evidence across endpoints rather than a strictly hierarchical framework. Analyses are descriptive and not powered for formal hypothesis testing.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Midlands
      • Nottingham, East Midlands, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
  • United States
    • California
      • Fresno, California, United States, 93720
        • Rao Dermotology West Coast -Site #4
      • San Diego, California, United States, 92108
        • Paradigm Research -Site #6
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research -site 08
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Oak Dermotology - site 07
      • Rolling Meadows, Illinois, United States, 60008
        • Arlington Dermatology - Site #1
    • Louisiana
      • Mandeville, Louisiana, United States, 70448
        • Clinical Trials Management, LLC- Site #5
    • New Jersey
      • Highlands, New Jersey, United States, 07716
        • Rao Dermatology - Site #3
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Hickory Dermatology Research Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • American Skin and Cancer Center - Site#2
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research Inc - site 11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Male or non-pregnant female ≥ 18 years of age at time of consent.
  2. Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline.

Key Exclusion Criteria:

  1. Pregnant, lactating, or planning to become pregnant.
  2. nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
  3. History of treated nBCC lesion recurrence or basal cell nevus syndrome.
  4. Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
  5. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
  6. Used the following topical agents within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinic acid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.
  7. Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm of the Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 200µg patch
D-MNA 200µg, intradermal patch, given on day 1, day 8, and day 15.
Drug: D-MNA 200µg
D-MNA, (doxorubicin) patch, 200µg
Active Comparator: 100µg patch
D-MNA 100µg intradermal patch, given on day 1, day 8, and day 15.
Drug: D-MNA 100µg
D-MNA (doxorubicin) patch, 100µg
Experimental: Device only (microneedle array alone) arm to assess mechanical and procedural effects.
P-MNA, intradermal patch, given on day 1, day 8, and day 15.
Other: Microneedle Array Alone
P-MNA patch, microneedle array alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological Clearance of Target Lesion
Time Frame: Day 29 or Day 57 following treatment, per protocol amendment.
Proportion of subjects with complete histological clearance of the Target Lesion at Visit 5/EV. Histological clearance represents pathological confirmation of treatment response and is interpreted in the context of overall clinical and histological outcomes.
Day 29 or Day 57 following treatment, per protocol amendment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Clearance of Target Lesion
Time Frame: Day 29 or Day 57 following treatment, per protocol amendment.
Proportion of subjects achieving complete clinical (visual) clearance of the Target Lesion at Visit 5 / Excision Visit, reflecting visible resolution of disease following treatment.
Day 29 or Day 57 following treatment, per protocol amendment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SkinJect, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Actual)

March 5, 2026

Study Completion (Actual)

March 13, 2026

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKNJCT-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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