Phase 2 Study Evaluating the Safety and Efficacy of Microneedle-mediated Delivery of Doxorubicin (D-MNA) in 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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06608238

Enrollment

Registered

2024-09-23

Start date

2024-09-03

Completion date

2026-03-13

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nodular Basal Cell Carcinoma

Keywords

Doxorubicin, Microneedle Array, Basal Cell Carcinoma

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.

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.

Interventions

DRUGD-MNA 200µg

D-MNA, (doxorubicin) patch, 200µg

DRUGD-MNA 100µg

D-MNA (doxorubicin) patch, 100µg

OTHERMicroneedle Array Alone

P-MNA patch, microneedle array alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double-blinded (Participant and Investigator)

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Histological Clearance of Target Lesion	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.

Secondary

Measure	Time frame	Description
Clinical Clearance of Target Lesion	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.

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026