Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

Universidad de Antioquia

Status and phase

Completed

Phase 3

Conditions

Skin Aging

Treatments

Drug: Methyl Aminolevulinate

Other: Moisturizer

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00629317

PISUI 2007-031

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

Female

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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.