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OpenTrials
Completed

NCT Number: NCT02373371

Actinic Keratoses Treatment With Metvix® in Combination With Light

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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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Limoges University Hospital

Limoges, 87042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metvix®

Drug

Photodynamic Therapy Blue light

Procedure

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

Photodynamic Therapy Daylight

Procedure

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

Primary outcomes

  1. Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12

    Time frame: Baseline and 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 outcomes

  1. Pain Assesment

    Time frame: at inclusion (after treatment)

    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).

  2. Lesions Disappearance Rate at 1 Months From Baseline.

    Time frame: 0(baseline),1 month

    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

  3. Lesions Disappearance Rate at 6 Months From Baseline.

    Time frame: 0(baseline), 6 month

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Feb 27, 2015
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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