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.
Phase 1/Phase 2
Eradication of lesion and HPV
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
18 Years - N/A
Accepts Healthy Volunteers
Peter Hillemanns, Md PhD, ,
Peter Hillemanns, Md PhD, Principal Investigator, Hannover Medical School