A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

Phase 1

Completed

• Conditions: Cervical Dysplasia
• Interventions: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

• Registration Number: NCT00369018
• Lead Sponsor: Photocure

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 Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Study First Posted: 2006-08-29
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-26
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAL 40, 12	methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	-
HAL 40, 3	methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	-
MAL 3	methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	-
MAL 12	methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	-
HAL 10, 3	methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	-
HAL 10, 12	methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	-

Primary Outcome Measures

Name	Time	Method
Lesion eradication	6 months

Secondary Outcome Measures

Name	Time	Method
Eradication of lesion and HPV	6 and 12 months
Safety assessment	6 months

Trial Locations

Locations (2)

Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology; 🇩🇪 Hannover, Germany

Ullevål University Hospital, Department of Obstetrics and Gynecology; 🇳🇴 Oslo, Norway