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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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

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Actinic Keratosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Metvix PDT

Group Type EXPERIMENTAL

Metvix PDT

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No