Completed
Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
What is being tested
Metvix®
+ Photodynamic Therapy Blue light
+ Photodynamic Therapy Daylight
DrugProcedure
Who is being recruted
Keratosis+3
+ Neoplasms
+ Precancerous Conditions
Over 18 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: March 2015
Summary
Principal SponsorUniversity Hospital, Limoges
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 25, 2015
Actual date on which the first participant was enrolled.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)
Official TitleEfficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Principal SponsorUniversity Hospital, Limoges
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
KeratosisNeoplasmsPrecancerous ConditionsSkin DiseasesSkin and Connective Tissue DiseasesKeratosis, Actinic
Criteria
2 inclusion criteria required to participate
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);
3 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorMetvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
Group II
ExperimentalMetvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center