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

Galderma R&D9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Actinic Keratosis

Interventions

Metvix PDTPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Dermatology of Manchester Royal Infirmary

Manchester, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 18.

Secondary Outcomes

Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15

Time frame: Baseline and Month15

Data from ClinicalTrials.gov

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