At a glance
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A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2)
In Brief
A Phase 2 clinical trial evaluating HAL 5% with illumination, HAL 1% with illumination, and 2 other interventions for Cervical Intraepithelial Neoplasia. Completed, enrolled 262 participants across 2 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation
Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation
Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation
Treatment with a singe dose of 2g placebo ointment, no photoactivation