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

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ClinicalTrials.gov Identifier: NCT00369018
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : November 30, 2010
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Cervical Dysplasia Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Lesion eradication [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Eradication of lesion and HPV [ Time Frame: 6 and 12 months ]
  2. Safety assessment [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00369018     History of Changes
Other Study ID Numbers: PC CE101/06
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010

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
Dermatologic Agents