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

Study Overview
=================
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.

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

Conditions
-----------------
Cervical Dysplasia

Intervention / Treatment
-----------------
* Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MAL 3<br> | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)<br>* MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application<br>|
| Active Comparator: MAL 12<br> | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)<br>* MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application<br>|
| Active Comparator: HAL 10, 3<br> | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)<br>* MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application<br>|
| Active Comparator: HAL 10, 12<br> | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)<br>* MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application<br>|
| Active Comparator: HAL 40, 3<br> | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)<br>* MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application<br>|
| Active Comparator: HAL 40, 12<br> | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)<br>* MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion eradication |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of lesion and HPV |  | 6 and 12 months | 
| Safety assessment |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
photodynamic therapy, methyl aminolevulinate, hexaminolevulinate, dose-finding, cervical dysplasia