NCT01256424

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Photocure · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	HAL 5% with illumination	Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation
DRUG	HAL 1% with illumination	Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation
DRUG	HAL 0.2% with illumination	Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation
DRUG	Placebo ointment without illumination	Treatment with a singe dose of 2g placebo ointment, no photoactivation

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2010-12-08
• Last updated: 2016-05-16
• Results posted: 2014-08-21

Locations

2 sites across 2 countries: Germany, Norway