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 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 Overview

• Status: Completed
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: Metvix®; Procedure: Photodynamic Therapy Daylight; Procedure: Photodynamic Therapy Blue light

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Limoges university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daylight; Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline	Drug: Metvix®; 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
Active Comparator: Conventional treatment; Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline	Drug: Metvix®; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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	0(baseline), 6 month

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2015
• Primary Completion (Actual): November 22, 2016
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Methyl 5-aminolevulinate
• Other Study ID Numbers: I14034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No