Clinical trial NCT00629317: Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Aging
Keywords: Skin Aging
Rejuvenation
Photodynamic Therapy
Methyl Aminolevulinate
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2008-03-06
Enrollment: 49
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Efficacy in facial global photodamage
timeFrame: 8 months
Secondary outcomes:
measure: Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia
timeFrame: 12 months
measure: Histological effect of MAL+PDT in fibrosis and new collagen formation
timeFrame: 12 months
measure: Safety and tolerance
timeFrame: 12 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: IPS Universitaria - Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Coordinator Group of Investigative Dermatology-GRID
name: Gloria Sanclemente, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Coordinator GRAEPIC
name: Hector I Garcia, Dr.
role: STUDY_CHAIR
References: