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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014