Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

Study Overview
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Brief Summary
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The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

Detailed Description
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It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested. Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented. The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage. Study Type: Interventional Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage

Conditions
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Skin Aging

Intervention / Treatment
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* Other: Moisturizer
* Drug: Methyl Aminolevulinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects older than 35 years of age and less than 75 years of age Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale Subjects willing to participate according to protocol requirements. Patients with signed Informed Consent Patients with no exclusion criteria Exclusion Criteria: Pregnant or nursing females. Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization. Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts ) Subjects with less than 6 months of previous rejuvenation interfering treatments Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.

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

Sexes Eligible for Study
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Female

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Methyl Aminolevulinate<br>* Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)<br>* Other names: Metvix;|
| Placebo Comparator: B<br> | Other: Moisturizer<br>* Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)<br>* Other names: Cetaphil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in facial global photodamage |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia |  | 12 months | 
| Histological effect of MAL+PDT in fibrosis and new collagen formation |  | 12 months | 
| Safety and tolerance |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Aging, Rejuvenation, Photodynamic Therapy, Methyl Aminolevulinate