Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369018
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2006-08-28
Brief Title:
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
Methyl Aminolevulinate MAL and Hexaminolevulinate HAL Photodynamic Therapy PDTof Cervical Intraepithelial Lesions SIL - a Double-blind Dose-finding Study
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None