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

Galderma

Status and phase

Completed

Phase 4

Conditions

Actinic Keratosis

Treatments

Procedure: Metvix PDT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01000636

RD.03.SPR.29061

Eudract # :2008-001603-30

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.