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NCT00369018 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT00369018
Other study ID # PC CE101/06
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 28, 2006
Last updated November 26, 2010
Start date August 2006
Est. completion date July 2009

Study information
Verified date November 2010
Source Photocure
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines AgencyGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

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

Intervention

Drug:
• methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

Locations
Country Name City State
Germany Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology Hannover
Norway Ullevål University Hospital, Department of Obstetrics and Gynecology Oslo

Sponsors (1)
Lead Sponsor Collaborator
Photocure

Countries where clinical trial is conducted

Germany,  Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lesion eradication 6 months
Secondary Eradication of lesion and HPV 6 and 12 months
Secondary Safety assessment 6 months
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