NCT00369018

A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Photocure · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).

Detailed description

Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients. This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.

Conditions

• Cervical Dysplasia

Interventions

Type	Name	Description
DRUG	methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-08-29
• Last updated: 2010-11-30

Locations

2 sites across 2 countries: Germany, Norway