Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

This study has been completed.
Sponsor:
Collaborator:
Galderma
Information provided by:
Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT00629317
First received: February 25, 2008
Last updated: March 13, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Skin Aging
Other: Moisturizer
Drug: Methyl Aminolevulinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • Efficacy in facial global photodamage [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Histological effect of MAL+PDT in fibrosis and new collagen formation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Safety and tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Methyl Aminolevulinate
Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
Other Name: Metvix
Placebo Comparator: B Other: Moisturizer
Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
Other Name: Cetaphil

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629317

Locations
Colombia
IPS Universitaria - Universidad de Antioquia
Medellin, Antioquia, Colombia, 01
Sponsors and Collaborators
Universidad de Antioquia
Galderma
Investigators
Principal Investigator: Gloria Sanclemente, Dr Coordinator Group of Investigative Dermatology-GRID
Study Chair: Hector I Garcia, Dr. Coordinator GRAEPIC
  More Information

No publications provided

Responsible Party: Gloria Sanclemente, MD, MSc., Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT00629317     History of Changes
Other Study ID Numbers: PISUI 2007-031
Study First Received: February 25, 2008
Last Updated: March 13, 2009
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:
Skin Aging
Rejuvenation
Photodynamic Therapy
Methyl Aminolevulinate

Additional relevant MeSH terms:
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014