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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAL 3 | Active Comparator |
| |
| MAL 12 | Active Comparator |
| |
| HAL 10, 3 | Active Comparator |
| |
| HAL 10, 12 | Active Comparator |
| |
| HAL 40, 3 | Active Comparator |
| |
| HAL 40, 12 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) | Drug | MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion eradication | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication of lesion and HPV | 6 and 12 months | |
| Safety assessment | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hillemanns, Md PhD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology | Hanover | 30625 | Germany | |||
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
| C419924 | 5-aminolevulinic acid hexyl ester |
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| Ullevål University Hospital, Department of Obstetrics and Gynecology |
| Oslo |
| 0407 |
| Norway |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |