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

Cervical Dysplasia Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00369018
Study type Interventional
Source Photocure
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 2006
Completion date July 2009
View Details
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