Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D-MNA 200µg · 1 trial · 1 indication
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...