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

Sponsor:	PhotoCure
Information provided by:	PhotoCure
ClinicalTrials.gov Identifier:	NCT00369018

Purpose

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).

Condition	Intervention	Phase
Cervical Dysplasia	Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study

Resource links provided by NLM:

Drug Information available for: Methyl aminolevulinate Fluoxymesterone Aminolevulinic acid Hexyl 5-aminolevulinate Aminolevulinic acid hydrochloride

U.S. FDA Resources

Further study details as provided by PhotoCure:

Primary Outcome Measures:

Lesion eradication [ Time Frame: 6 months ]

Secondary Outcome Measures:

Eradication of lesion and HPV [ Time Frame: 6 and 12 months ]
Safety assessment [ Time Frame: 6 months ]

Estimated Enrollment:	96
Study Start Date:	August 2006
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: MAL 3	Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: MAL 12	Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 10, 3	Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 10, 12	Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 40, 3	Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 40, 12	Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369018

Locations

Germany
Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology
Hannover, Germany, 30625
Norway
Ullevål University Hospital, Department of Obstetrics and Gynecology
Oslo, Norway, 0407

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

Peter Hillemanns, Md PhD

Hannover Medical School

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00369018 History of Changes
Other Study ID Numbers:	PC CE101/06
Study First Received:	August 28, 2006
Last Updated:	November 26, 2010
Health Authority:	Norway: Norwegian Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by PhotoCure:

photodynamic therapy
methyl aminolevulinate
hexaminolevulinate
dose-finding
cervical dysplasia

Additional relevant MeSH terms:

Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012