Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

March 13, 2009 updated by: Universidad de Antioquia

A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 01
        • IPS Universitaria - Universidad de Antioquia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Methyl Aminolevulinate
Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
Other Names:
  • Metvix
Placebo Comparator: B
Other: Moisturizer
Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
Other Names:
  • Cetaphil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy in facial global photodamage
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia
Time Frame: 12 months
12 months
Histological effect of MAL+PDT in fibrosis and new collagen formation
Time Frame: 12 months
12 months
Safety and tolerance
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Collaborators

Galderma R&D

Investigators

  • Principal Investigator: Gloria Sanclemente, Dr, Coordinator Group of Investigative Dermatology-GRID
  • Study Chair: Hector I Garcia, Dr., Coordinator GRAEPIC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2009

Last Update Submitted That Met QC Criteria

March 13, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PISUI 2007-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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