Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

Study Overview
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Brief Summary
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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

Official Title
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A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage

Conditions
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Facial Photodamage

Intervention / Treatment
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* Drug: Methyl Aminolevulinate (MAL)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methyl Aminolevulinate (MAL)<br>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)<br> <br> * Other names: Metvix®;|
| Placebo Comparator: Placebo<br>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<br> <br> * Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global photodamage improvement | The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale. | 1 month after third session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement | Pain evaluation with the visual analogue scale after 2 hours of sun exposure in each of the sessions performed (Sessions 1, 2 and 3). | After 2 hours of sun exposure in each session | 
| Specific Photodamage score | 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. | 1 month after the third session | 
| Sun irradiance and illuminance quantification | Sun irradiation and illuminance quantification during exposure | During the 2 hours of each session | 
| Adverse events | Any adverse event | From recruitment until 1 month after the third session | 
| Therapy tolerance | Therapy tolerance will be recorded with a scale that includes a 4-grade severity score for oozing, erythema, oedema, desquamation, pigmentation, and vesiculation. | 1 week after sessions 1,2 and 3 | 
| Quality of life assessment (Skindex-29 Instrument) | Quality of life assessment (Skindex-29 Instrument) | Basal and 1 month after the third session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized-controlled-trial, Methyl-Aminolevulinate, Daylight, Photodynamic-therapy