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Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses (CoMet)

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ClinicalTrials.gov Identifier: NCT01475071
Recruitment Status : Completed
First Posted : November 21, 2011
Results First Posted : April 18, 2016
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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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 with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: Metvix and natural daylight PDT Drug: Metvix and conventional PDT Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.
Study Start Date : March 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Metvix and daylight Drug: Metvix and natural daylight PDT
Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
Active Comparator: Metvix and lamp Drug: Metvix and conventional PDT
Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.


Outcome Measures
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Primary Outcome Measures :
  1. Lesion Response [ Time Frame: Week12 ]
    Percent of lesions treated at Baseline, in complete response at Week 12

  2. Pain Score [ Time Frame: Baseline (during procedure), assessed after procedure ]
    Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)


Eligibility Criteria
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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:

  1. Male or female above 18 years;
  2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria:

  1. Subject with clinical diagnosis of at least one severe AK on TAs
  2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
  3. Subject with pigmented AK on the TAs
Contacts and Locations
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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): NCT01475071


Locations
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Australia, Australian Capital Territory
Galderma Investigational site
Phillip, Australian Capital Territory, Australia
Australia, New South Wales
Galderma Investigational Site
Kogarah, New South Wales, Australia
Galderma Investigational site
Sydney, New South Wales, Australia
Galderma Investigational site
Westmead, New South Wales, Australia
Australia, Queensland
Galderma Investigational site
Woolloongabba, Queensland, Australia
Australia, Victoria
Galderma Investigational site
Carlton, Victoria, Australia
Sponsors and Collaborators
Galderma R&D
Investigators
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Principal Investigator: Stephen Shumack St George Dermatology and skin Cancer Center
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01475071    
Other Study ID Numbers: RD.03.SPR.29102
First Posted: November 21, 2011    Key Record Dates
Results First Posted: April 18, 2016
Last Update Posted: February 18, 2021
Last Verified: March 2016
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
 Methyl 5-aminolevulinate
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents