Skin Aging Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage
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.
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.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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