Actinic Keratoses Treatment With Metvix® in Combination With Light

University Hospital, Limoges26 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Actinic Keratoses

Interventions

Metvix®DRUG

Photodynamic Therapy Blue lightPROCEDURE

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 DaylightPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female above 18 years; * Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs); Exclusion Criteria: * Subject with clinical diagnosis of at least one severe AK on TAs * Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs; * Subject with pigmented AK on the TAs

Locations (1)

Limoges University Hospital

Limoges, France

Outcomes

Primary Outcomes

Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12

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.

Time frame: Baseline and Week 12

Secondary Outcomes

Pain Assesment

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).

Time frame: at inclusion (after treatment)

Lesions Disappearance Rate at 1 Months From Baseline.

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

Time frame: 0(baseline),1 month

Lesions Disappearance Rate at 6 Months From 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

Time frame: 0(baseline), 6 month

Data from ClinicalTrials.gov

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