at baseline (mild effect on QoL) to 0.38 (no effect on QoL) at the EOS/day 84 visit.
The clinical development of VP-102 addresses these issues by seeking FDA approval of a standardized, shelf-stable formulation of cantharidin delivered via a proprietary, single-use applicator. The small tip of the applicator is designed to improve safety and efficacy by targeting MC lesions and sparing surrounding healthy skin, while the gentian violet surgical dye in the solution may assist in reducing duplicative dosing of individual lesions in a single treatment. The single-use applicator may also reduce the potential for cross-contamination, as direct contact with the skin is not necessary for application, and the applicator is not to be used across multiple patients.
Systemic exposure to cantharidin was negligible in this pediatric patient population, as evidenced by 65/66 plasma samples being below the LLOQ. These findings and the incidence of AEs support the safety of VP-102 to treat MC in the pediatric population. Complete clearance of MC lesions was observed in 48.5% of all VP-102-treated subjects and VP-102 treatment reduced the number of lesions by an average of 90.4% at the EOS/day 84 visit compared to baseline. On the CDLQI, subjects showed an improvement in QoL from a mild effect of disease at baseline to no effect at the end of the study.
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