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

SkinJect

Status and phase: Completed; Phase 2

Conditions: Nodular Basal Cell Carcinoma

Treatments: Other: Microneedle Array Alone; Drug: D-MNA 100µg; Drug: D-MNA 200µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06608238

SKNJCT-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

200µg patch

Active Comparator group

Description:

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

Treatment:

Drug: D-MNA 200µg

100µg patch

Active Comparator group

Description:

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

Treatment:

Drug: D-MNA 100µg

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

Experimental group

Description:

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

Treatment:

Other: Microneedle Array Alone