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

February 25, 2008
March 13, 2009
February 2008
January 2009   (final data collection date for primary outcome measure)
Efficacy in facial global photodamage [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00629317 on ClinicalTrials.gov Archive Site
  • 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 ]
1-Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia 2-Histological effect of MAL+PDT in fibrosis and new collagen formation 3-Safety and tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Skin Aging
  • Other: Moisturizer
    Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
    Other Name: Cetaphil
  • Drug: Methyl Aminolevulinate
    Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
    Other Name: Metvix
  • Active Comparator: A
    Intervention: Drug: Methyl Aminolevulinate
  • Placebo Comparator: B
    Intervention: Other: Moisturizer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
March 2009
January 2009   (final data collection date for primary outcome measure)

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.
Female
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00629317
PISUI 2007-031
No
Gloria Sanclemente, MD, MSc., Universidad de Antioquia
Universidad de Antioquia
Galderma
Principal Investigator: Gloria Sanclemente, Dr Coordinator Group of Investigative Dermatology-GRID
Study Chair: Hector I Garcia, Dr. Coordinator GRAEPIC
Universidad de Antioquia
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP