- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00369018
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MAL 3
|
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
Active Comparator: MAL 12
|
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
Active Comparator: HAL 10, 3
|
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
Active Comparator: HAL 10, 12
|
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
Active Comparator: HAL 40, 3
|
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
Active Comparator: HAL 40, 12
|
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lesion eradication
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Eradication of lesion and HPV
Time Frame: 6 and 12 months
|
6 and 12 months
|
Safety assessment
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Hillemanns, Md PhD, Hannover Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Carcinoma in Situ
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Photosensitizing Agents
- Dermatologic Agents
- Aminolevulinic Acid
- Methyl 5-aminolevulinate
Other Study ID Numbers
- PC CE101/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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