Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage
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|ClinicalTrials.gov Identifier: NCT00629317|
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : March 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Skin Aging||Other: Moisturizer Drug: Methyl Aminolevulinate||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||March 2009|
|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
- Efficacy in facial global photodamage [ Time Frame: 8 months ]
- Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia [ Time Frame: 12 months ]
- Histological effect of MAL+PDT in fibrosis and new collagen formation [ Time Frame: 12 months ]
- Safety and tolerance [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|