NCT01000636

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
PROCEDURE	Metvix PDT	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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-10-23
• Last updated: 2021-05-26
• Results posted: 2021-05-26

Locations

1 site across 1 country: United Kingdom