A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
NCT ID: NCT00369018
Last Updated: 2010-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
96 participants
INTERVENTIONAL
2006-08-31
2009-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MAL 3
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
MAL 12
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
HAL 10, 3
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
HAL 10, 12
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
HAL 40, 3
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
HAL 40, 12
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Interventions
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methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with AGUS
* Patients with invasive disease
* Patients with porphyria
* Patients sensitive to MAL and HAL
18 Years
FEMALE
No
Sponsors
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Photocure
INDUSTRY
Principal Investigators
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Peter Hillemanns, Md PhD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology
Hanover, , Germany
Ullevål University Hospital, Department of Obstetrics and Gynecology
Oslo, , Norway
Countries
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Other Identifiers
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PC CE101/06
Identifier Type: -
Identifier Source: org_study_id