Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

Last updated: March 13, 2009
Sponsor: Universidad de Antioquia
Overall Status: Completed

Phase

3

Condition

Skin Aging

Treatment

N/A

Clinical Study ID

NCT00629317
PISUI 2007-031
  • Ages 35-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 Globalphotodamage scale

  • Subjects willing to participate according to protocol requirements.

  • Patients with signed Informed Consent

  • Patients with no exclusion criteria

Exclusion

Exclusion Criteria:

  • Pregnant or nursing females.

  • Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or anyother photosensitizing disorder or drug induced photosensitization.

  • Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facialwarts )

  • Subjects with less than 6 months of previous rejuvenation interfering treatments

  • Subjects requiring concurrent treatment that would interfere with study objectivesand/or assessments.

Study Design

Total Participants: 49
Study Start date:
February 01, 2008
Estimated Completion Date:
March 31, 2009

Study 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.

Connect with a study center

  • IPS Universitaria - Universidad de Antioquia

    Medellin, Antioquia 01
    Colombia

    Site Not Available

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