Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.

Detailed Description
-----------------
In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.

Official Title
-----------------
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Procedure: Metvix PDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant with an history of immunosuppression from 5 to 15 years, Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the scalp, forearms or the chest. Exclusion Criteria: At risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®, AK lesions clinically atypical or suspicious for malignancy on the target field, Any of the following topical treatments within the specified washout period at Screening: 5-FU, Imiquimod, Diclofenac sodium: 3 months, Cryotherapy: 3 months, PDT: 3 months, Other less common AK treatments: 3 months. Systemic retinoids within the last month prior to Screening visit.

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

Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metvix PDT<br> | Procedure: Metvix PDT<br>* Methyl aminolevulinate cream will be applied for 3 hours on the whole target field. The target field will then be exposed to red light using Aktilite 128 lamp.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lesion Count at Week 18 | Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100. | Baseline and Week 18. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15 |  | Baseline and Month15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplant patients, Actinic Keratoses, Metvix PDT, Field cancerisation, Gene expression