Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Methyl 5-aminolevulinate

Aminolevulinic Acid

Photosensitizing Agents

Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline

Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline

Metvix®

Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug

Photodynamic Therapy Blue light

Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug

Photodynamic Therapy Daylight

The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in subjects with mild actinic keratoses (intra-individual comparison)

Actinic Keratoses Treatment With Metvix® in Combination With Light

Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

The number of lesions is assessed at baseline (before treatment) and 12 weeks later.

The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients.

Pain assesment with a VAS Pain scale

Visual analog scale \[VAS\] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

The number of lesions is assessed at baseline (before treatment) and 1 month later.

The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 1 month "/nubmer of lesions at baseline

The number of lesions is assessed at baseline (before treatment) and 6 month later.

The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 6 month "/nubmer of lesions at baseline

Galderma R&D

University Hospital, Limoges

Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline

Metvix®

Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug

Daylight

Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline

Metvix®

Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug

Conventional Treatment

Total

Age, Continuous

Sex: Female, Male

France

Region of Enrollment

Project Manager

Main analysis:

* nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,
* nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,

The primary endpoint is:

differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether "difference M3" is significantly different from 0

Spots Global Cancer Trial Database for Actinic Keratoses Treatment With Metvix® in Combination With Light

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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