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

NCT06608238 | Completed Phase 2 FDA Drug

• 1 other identifier: SKNJCT-003
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 11

Brief 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

Keywords

Doxorubicin; Microneedle Array; Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Histological Clearance of Target Lesion

  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 Outcomes (1)

• Clinical Clearance of Target Lesion

  Day 29 or Day 57 following treatment, per protocol amendment.

Study Arms (3)

200µg patch

ACTIVE COMPARATOR

D-MNA 200µg, intradermal patch, given on day 1, day 8, and day 15.

Drug: D-MNA 200µg

100µg patch

ACTIVE COMPARATOR

D-MNA 100µg intradermal patch, given on day 1, day 8, and day 15.

Drug: D-MNA 100µg

Device only (microneedle array alone) arm to assess mechanical and procedural effects.

EXPERIMENTAL

P-MNA, intradermal patch, given on day 1, day 8, and day 15.

Other: Microneedle Array Alone

Interventions

Microneedle Array Alone OTHER

P-MNA patch, microneedle array alone

Device only (microneedle array alone) arm to assess mechanical and procedural effects.

D-MNA 200µg DRUG

D-MNA, (doxorubicin) patch, 200µg

200µg patch

D-MNA 100µg DRUG

D-MNA (doxorubicin) patch, 100µg

100µg patch

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female ≥ 18 years of age at time of consent.
• 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.

You may not qualify if:

• Pregnant, lactating, or planning to become pregnant.
• nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
• History of treated nBCC lesion recurrence or basal cell nevus syndrome.
• Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
• Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
• 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.
• 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.

Sponsors & Collaborators

• SkinJect, Inc.: lead

Study Sites (11)

Rao Dermotology West Coast -Site #4

Fresno, California, 93720, United States

Location

Paradigm Research -Site #6

San Diego, California, 92108, United States

Location

Therapeutics Clinical Research -site 08

San Diego, California, 92123, United States

Location

Oak Dermotology - site 07

Naperville, Illinois, 60563, United States

Location

Arlington Dermatology - Site #1

Rolling Meadows, Illinois, 60008, United States

Location

Clinical Trials Management, LLC- Site #5

Mandeville, Louisiana, 70448, United States

Location

Rao Dermatology - Site #3

Highlands, New Jersey, 07716, United States

Location

HIckory Dermatology Research Center

Hickory, North Carolina, 28602, United States

Location

American Skin and Cancer Center - Site#2

Knoxville, Tennessee, 37909, United States

Location

Virginia Clinical Research Inc - site 11

Norfolk, Virginia, 23502, United States

Location

Nottingham University Hospitals NHS Trust

Nottingham, East Midlands, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded (Participant and Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 90 patients randomized in a 1:1:1 ratio to receive microneedle array (P-MNA) alone or D-MNA at dose levels of 100µg or 200µg.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: September 3, 2024
• Primary Completion: March 5, 2026
• Study Completion: March 13, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

GB (1); US (10)