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

This study is currently recruiting participants.
Verified by Universidad de Antioquia, February 2008

Sponsors and Collaborators: Universidad de Antioquia
Galderma
Information provided by: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT00629317
  Purpose

The aim of the study is to determine the efficacy of MAL + Aktilite vs placebo + Aktilite in facial photodamage in a randomized double blind trial.


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

MedlinePlus related topics:   Skin Aging   

ChemIDplus related topics:   Aminolevulinic acid    Aminolevulinic acid hydrochloride    Methyl aminolevulinate   

U.S. FDA Resources

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

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:
  • 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 ]

Estimated Enrollment:   50
Study Start Date:   February 2008
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator Drug: Methyl Aminolevulinate
Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
B: Placebo Comparator Other: Moisturizer
Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)

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

Contacts
Contact: Gloria Sanclemente, Dr.     574-2630171 ext 123     gsanclemente@une.net.co    
Contact: Hector I Garcia, Dr     574-2106060     hgarcia@une.net.co    

Locations
Colombia, Antioquia
IPS Universitaria - Universidad de Antioquia     Recruiting
      Medellin, Antioquia, Colombia, 01
      Contact: Leon Montaño, Dr     574-2630171 ext 100        
      Sub-Investigator: John F Villa            
      Sub-Investigator: Marcela Barrera            
      Sub-Investigator: Leonardo Medina, Dr            
      Principal Investigator: Gloria Sanclemente, Dr            

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

Responsible Party:   Universidad de Antioquia ( Gloria Sanclemente, MD, MSc. )
Study ID Numbers:   PISUI 2007-031
First Received:   February 25, 2008
Last Updated:   March 4, 2008
ClinicalTrials.gov Identifier:   NCT00629317
Health Authority:   Colombia: Institutional Review Board

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

Study placed in the following topic categories:
Facies
Methyl 5-aminolevulinate
Aminolevulinic Acid

Additional relevant MeSH terms:
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008




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