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

Photocure96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cervical Dysplasia

Interventions

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)DRUG

MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology

Hanover, Germany

Ullevål University Hospital, Department of Obstetrics and Gynecology

Oslo, Norway

Outcomes

Primary Outcomes

Lesion eradication

Time frame: 6 months

Secondary Outcomes

Eradication of lesion and HPV

Time frame: 6 and 12 months

Safety assessment

Time frame: 6 months

Data from ClinicalTrials.gov

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