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Actinic Keratoses Treatment With Metvix® in Combination With Light

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373371
Recruitment Status : Completed
First Posted : February 27, 2015
Results First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Galderma
Information provided by (Responsible Party):
University Hospital, Limoges

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)

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: Metvix® Procedure: Photodynamic Therapy Blue light Procedure: Photodynamic Therapy Daylight Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Actual Study Start Date : March 25, 2015
Actual Primary Completion Date : November 22, 2016
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373371


Locations
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France
Limoges University Hospital
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Galderma
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02373371    
Other Study ID Numbers: I14034
First Posted: February 27, 2015    Key Record Dates
Results First Posted: April 8, 2019
Last Update Posted: April 8, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents