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

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.

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.