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Actinic Keratoses Treatment With Metvix® in Combination With Light

Primary Purpose

Actinic Keratoses

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Metvix®
Photodynamic Therapy Blue light
Photodynamic Therapy Daylight
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Limoges University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daylight

Conventional treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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
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

Full Information

First Posted
February 16, 2015
Last Updated
January 9, 2019
Sponsor
University Hospital, Limoges
Collaborators
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02373371
Brief Title
Actinic Keratoses Treatment With Metvix® in Combination With Light
Official Title
Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 25, 2015 (Actual)
Primary Completion Date
November 22, 2016 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
Collaborators
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daylight
Arm Type
Experimental
Arm Description
Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
Intervention Type
Drug
Intervention Name(s)
Metvix®
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy Blue light
Intervention Description
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
Intervention Name(s)
Photodynamic Therapy Daylight
Intervention Description
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
Description
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 Outcome Measure Information:
Title
Pain Assesment
Description
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)
Title
Lesions Disappearance Rate at 1 Months From Baseline.
Description
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
Title
Lesions Disappearance Rate at 6 Months From Baseline.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

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Actinic Keratoses Treatment With Metvix® in Combination With Light

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