Skin Aging
Conditions
Keywords
Skin Aging, Rejuvenation, Photodynamic Therapy, Methyl Aminolevulinate
Brief 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.
Interventions
OTHERMoisturizer
Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
Sponsors
Galderma R&D
Universidad de Antioquia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in facial global photodamage | 8 months |
Secondary
| Measure | 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 |
Countries
Colombia
Outcome results
None listed