Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06608238 | Phase 2 Study Evaluating the Safety and Efficacy of Microneedle-mediated Delivery of Doxorubicin (D-MNA) in Patients With Nodular Basal Cell Carcinoma. | PHASE2 | COMPLETED | 90 | — | — | Sep 3, 2024 | Mar 13, 2026 | May 4, 2026 | 11 | United States, United Kingdom |
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.
| Arm | Type | Description |
|---|---|---|
| 200µg patch | ACTIVE_COMPARATOR | D-MNA 200µg, intradermal patch, given on day 1, day 8, and day 15. |
| 100µg patch | ACTIVE_COMPARATOR | D-MNA 100µg intradermal patch, given on day 1, day 8, and day 15. |
| 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. |
| Name | Type | Description |
|---|---|---|
| D-MNA 200µg | DRUG | D-MNA, (doxorubicin) patch, 200µg |
| D-MNA 100µg | DRUG | D-MNA (doxorubicin) patch, 100µg |
| Microneedle Array Alone | OTHER | P-MNA patch, microneedle array alone |
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 an...