NCT00629317

Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Universidad de Antioquia · Academic / Other
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Skin Aging

Interventions

Type	Name	Description
OTHER	Moisturizer	Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
DRUG	Methyl Aminolevulinate	Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2008-03-06
• Last updated: 2009-03-16

Locations

1 site across 1 country: Colombia