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Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00629317
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : March 16, 2009
Information provided by:
Universidad de Antioquia

Brief Summary:
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 or disease Intervention/treatment Phase
Skin Aging Other: Moisturizer Drug: Methyl Aminolevulinate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage
Study Start Date : February 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy in facial global photodamage [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia [ Time Frame: 12 months ]
  2. Histological effect of MAL+PDT in fibrosis and new collagen formation [ Time Frame: 12 months ]
  3. Safety and tolerance [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00629317

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IPS Universitaria - Universidad de Antioquia
Medellin, Antioquia, Colombia, 01
Sponsors and Collaborators
Universidad de Antioquia
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Principal Investigator: Gloria Sanclemente, Dr Coordinator Group of Investigative Dermatology-GRID
Study Chair: Hector I Garcia, Dr. Coordinator GRAEPIC
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Responsible Party: Gloria Sanclemente, MD, MSc., Universidad de Antioquia Identifier: NCT00629317    
Other Study ID Numbers: PISUI 2007-031
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009
Keywords provided by Universidad de Antioquia:
Skin Aging
Photodynamic Therapy
Methyl Aminolevulinate
Additional relevant MeSH terms:
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Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents