Status:
COMPLETED
Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage
Lead Sponsor:
Universidad de Antioquia
Collaborating Sponsors:
Galderma R&D
Conditions:
Skin Aging
Eligibility:
FEMALE
35-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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 exclusion criteria
Exclusion
- Pregnant or nursing females.
- Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.
- Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )
- Subjects with less than 6 months of previous rejuvenation interfering treatments
- Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00629317
Start Date
February 1 2008
End Date
March 1 2009
Last Update
March 16 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IPS Universitaria - Universidad de Antioquia
Medellín, Antioquia, Colombia, 01