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Completed

NCT Number: NCT00369018

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

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).

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Key information

Conditions

Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology, Hanover, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

Drug

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

Primary outcomes

  1. Lesion eradication

    Time frame: 6 months

Secondary outcomes

  1. Eradication of lesion and HPV

    Time frame: 6 and 12 months

  2. Safety assessment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Photocure

Industry

Registry information

Official study title

Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2006
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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