drugset / Trial / NCT01256424

Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia

NCT01256424

Phase 2 Completed 262 enrolled Photocure
RandomizedParallel-groupQuadruple-blindTreatment

Summary

An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).

Timeline

Start
2011-04
Primary completion
2012-09
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject hexaminolevulinate Small molecule 0.2 % Topical
Subject hexaminolevulinate Small molecule 1 % Topical
Subject hexaminolevulinate Small molecule 5 % Topical
Subject hexaminolevulinate Small molecule 2 g Topical