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

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).

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.

Inclusion Criteria:

• Positive histology of CIN 1-3

Exclusion Criteria:

• Patients with endocervical lesions
• Patients with AGUS
• Patients with invasive disease
• Patients with porphyria
• Patients sensitive to MAL and HAL