Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

Photosensitizing Agents

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.

Metvix PDT

John T. Lear, MB,Ch.B,M.D

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.

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

Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100.

Galderma R&D

Questioning of subjects at each follow up visit

Metvix® Photodynamic Therapy (PDT)

Age, Categorical

Age, Continuous

Sex: Female, Male

United Kingdom

Region of Enrollment

Only 9 subjects out of 10 planned ones by the protocol have been included

Farzaneh SIDOU Clinical Project Manager

This trial was of exploratory nature, no statistical rationale for sample size exists. Analysis was performed on Intent to treat (ITT) population that consisted of the entire population enrolled and randomized (i.e., assigned a treatment number). Here, "Overall Number of Participants Analyzed" = participants with available data at specified time point.

Percent Change From Baseline in Lesion Count at Week 18

This trial is of exploratory nature, no statistical rationale for sample size exists. This population consists of the entire population enrolled and randomized (i.e., assigned a treatment number).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)	NCT01000636	Actinic Keratos...	Metvix PDT	18 Years -	Galderma R&D
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)	NCT01000636	Actinic Keratos...	Metvix PDT	18 Years -	Galderma R&D

Spots Global Cancer Trial Database for field cancerisation