Actinic Keratoses Treatment With Metvix® in Combination With Light

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-25

Study Completion Date

2018-06-01

Brief Summary

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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)

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Detailed Description

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Conditions

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Actinic Keratoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daylight

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

Group Type EXPERIMENTAL

Metvix®

Intervention Type DRUG

Photodynamic Therapy Daylight

Intervention Type PROCEDURE

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

Conventional treatment

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

Group Type ACTIVE_COMPARATOR

Metvix®

Intervention Type DRUG

Photodynamic Therapy Blue light

Intervention Type PROCEDURE

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

Interventions

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Metvix®

Intervention Type DRUG

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No