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Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

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ClinicalTrials.gov Identifier: NCT02139618
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : March 6, 2015
Sponsor:
Collaborators:
Grupo de Investigacion Dermatologica (GRID)
IPS Universitaria-Universidad de Antioquia
Information provided by (Responsible Party):
Fundación Dermabase

Study Description
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Brief Summary:
Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage

Condition or disease Intervention/treatment Phase
Facial Photodamage Drug: Methyl Aminolevulinate (MAL) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Methyl Aminolevulinate (MAL)
1 gram of Topical Methyl Aminolevulinate (MAL) applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
 Drug: Methyl Aminolevulinate (MAL)
Other Name: Metvix®
Placebo Comparator: Placebo
1 gram of placebo cream applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
 Drug: Placebo
Other Name: Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Global photodamage improvement [ Time Frame: 1 month after third session ]
    The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.


Secondary Outcome Measures :
  1. Pain measurement [ Time Frame: After 2 hours of sun exposure in each session ]
    Pain evaluation with the visual analogue scale after 2 hours of sun exposure in each of the sessions performed (Sessions 1, 2 and 3).

  2. Specific Photodamage score [ Time Frame: 1 month after the third session ]
    Specific photodamage severity score for fine lines, coarse lines, tactile roughness, mottled pigmentation, sallowness, and erythema one month after the third daylight PDT session, according to Dover´s photodamage scale.

  3. Sun irradiance and illuminance quantification [ Time Frame: During the 2 hours of each session ]
    Sun irradiation and illuminance quantification during exposure

  4. Adverse events [ Time Frame: From recruitment until 1 month after the third session ]
    Any adverse event

  5. Therapy tolerance [ Time Frame: 1 week after sessions 1,2 and 3 ]
    Therapy tolerance will be recorded with a scale that includes a 4-grade severity score for oozing, erythema, oedema, desquamation, pigmentation, and vesiculation.

  6. Quality of life assessment (Skindex-29 Instrument) [ Time Frame: Basal and 1 month after the third session ]
    Quality of life assessment (Skindex-29 Instrument)


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
  • Patients willing to participate
  • Signed informed consent

Exclusion Criteria:

  • Pregnant or nursing females
  • Subjects with any photosensitizing disorder
  • Any active infectious skin disorder
  • History of herpes simplex in the face
  • Subjects with less than 6 months of any previous rejuvenation interfering treatments
  • History of systemic isotretinoin in the last year
  • Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments
  • History of hypersensitivity reactions
  • Activities with high sun exposure during 48 hours after treatment
  • Clinical suspicion of any systemic or local malignancy
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): NCT02139618


Locations
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Colombia
IPS Universitaria
Medellin, Antioquia, Colombia, 01
Sponsors and Collaborators
Fundación Dermabase
Grupo de Investigacion Dermatologica (GRID)
IPS Universitaria-Universidad de Antioquia
Investigators
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Principal Investigator: Gloria Sanclemente, Dr Universidad de Antioquia. Medellin, Colombia
More Information
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Responsible Party: Fundación Dermabase
ClinicalTrials.gov Identifier: NCT02139618    
Other Study ID Numbers: 2013-01INT
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Fundación Dermabase:
Randomized-controlled-trial
Methyl-Aminolevulinate
Daylight
Photodynamic-therapy
Additional relevant MeSH terms:
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Facies
Disease Attributes
Pathologic Processes
Aminolevulinic Acid
 Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents