Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Peter Hillemanns, Md PhD
Hannover Medical School
Norway: Norwegian Medicines Agency