Trial of Methyl Aminolevulinate Plus Aktilite in 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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage|
- Efficacy in facial global photodamage [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Histological effect of MAL+PDT in fibrosis and new collagen formation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Safety and tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Drug: Methyl Aminolevulinate
Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
Other Name: Metvix
|Placebo Comparator: B||
Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
Other Name: Cetaphil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629317
|IPS Universitaria - Universidad de Antioquia|
|Medellin, Antioquia, Colombia, 01|
|Principal Investigator:||Gloria Sanclemente, Dr||Coordinator Group of Investigative Dermatology-GRID|
|Study Chair:||Hector I Garcia, Dr.||Coordinator GRAEPIC|