Brief Title
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
Official Title
Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
Brief 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Lesion eradication
Secondary Outcome
Eradication of lesion and HPV
Condition
Cervical Dysplasia
Intervention
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
Study Arms / Comparison Groups
MAL 3
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
96
Start Date
August 2006
Completion Date
July 2009
Primary Completion Date
July 2009
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Peter Hillemanns, Md PhD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00369018
Organization ID
PC CE101/06
Study Sponsor
Photocure
Study Sponsor
Peter Hillemanns, Md PhD, Principal Investigator, Hannover Medical School
Verification Date
November 2010