Completed

COMET2Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis

What is being tested

NDL-PDT

+ c-PDT

+ NDL-PDT

Drug

Who is being recruted

Keratosis+3

+ Neoplasms

+ Precancerous Conditions

Over 18 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: July 2013

See protocol details

Summary

Principal SponsorGalderma R&D

Last updated: February 18, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study. The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

NCT01821391

Principal SponsorGalderma R&D

Last updated: February 18, 2021

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

131 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

Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas

Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs

4 exclusion criteria prevent from participating

Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons

Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas

Subject with pigmented AK on the treated areas

Subject with porphyria

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

Experimental

Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy

Group II

Experimental

Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy

Study Objectives

Primary 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 18 locations

Investigative site

Montpellier, FranceOpen Investigative site in Google Maps

Investigational site

Nantes, France

Investigational site

Nice, France

Investigational site

Paris, France

Completed18 Study Centers