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

Primary Purpose

Cervical Dysplasia

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

About this trial

This is an interventional treatment trial for Cervical Dysplasia focused on measuring photodynamic therapy, methyl aminolevulinate, hexaminolevulinate, dose-finding, cervical dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology
Ullevål University Hospital, Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Arm Label

MAL 3

MAL 12

HAL 10, 3

HAL 10, 12

HAL 40, 3

HAL 40, 12

Arm Description

Outcomes

Primary Outcome Measures

Lesion eradication

Secondary Outcome Measures

Eradication of lesion and HPV

Safety assessment

Full Information

NCT ID

NCT00369018

First Posted

August 28, 2006

Last Updated

November 26, 2010

Sponsor

Photocure

1. Study Identification

Unique Protocol Identification Number

NCT00369018

Brief Title

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

Official Title

Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Photocure

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Dysplasia

Keywords

photodynamic therapy, methyl aminolevulinate, hexaminolevulinate, dose-finding, cervical dysplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MAL 3

Arm Type

Active Comparator

Arm Title

MAL 12

Arm Type

Active Comparator

Arm Title

HAL 10, 3

Arm Type

Active Comparator

Arm Title

HAL 10, 12

Arm Type

Active Comparator

Arm Title

HAL 40, 3

Arm Type

Active Comparator

Arm Title

HAL 40, 12

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

Intervention Description

MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

Primary Outcome Measure Information:

Title

Lesion eradication

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Eradication of lesion and HPV

Time Frame

6 and 12 months

Title

Safety assessment

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Hillemanns, Md PhD

Organizational Affiliation

Hannover Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Ullevål University Hospital, Department of Obstetrics and Gynecology

City

Oslo

ZIP/Postal Code

0407

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

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

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