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Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin (PDT)

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: NCT00843323
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : June 11, 2010
University of Regensburg
Information provided by:
University of Sao Paulo

Brief Summary:
In this study, 26 patients were selected and included for full-face photodynamic therapy sessions. All patients presented signs of photoaging skin and multiple actinic keratosis. Photographs and Biopsies were taken before and after the procedure. Clinical and histological aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor expression were evaluated.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Photoaging Solar Elastosis Other: Methylaminolevulinate - photodynamic therapy Not Applicable

Detailed Description:

Study design:

Patients and methods:

26 patients (16 females, 8 males) age 35-90 years, mean 59,4 y Skin types I-IV, severely photodamaged facial skin Multiples Aks on the face ( total 268) minimum of 3 per patient Approved by local ethical committee and informed consent given

Treatment procedure:

Prior curettage Full-face MAL application ( Metvix ®, Galderma France) 1,5 tube per treatment Incubation time 3 hs - in the first treatment session; and 1,5 h - in the 2 nd and 3 rd sessions Illumination LED (Aktilite® Photocure, Norway) 635 nm 37 J/cm2 3 treatments performed, one month apart Pain monitoring: forced air cooling device


Clinical - 5 point scale based on Dover's and Zane's studies Dover JS et al. Topical ALA combined with IPL in photoaging. Arch Dermatol 2005; 141: 1247-52 Zane et al. Clinical and echographical analysis of MAL- PDT in photodamaged skin. Laser Surg Med 2007; 39: 203-9

Histological - Hematoxilin- Eosin staining

Immunohistochemical study- HP 53, Metalloproteinases, Procollagen I,

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT
Study Start Date : December 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Methylaminolevulinate - photodynamic therapy
    Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with severe photodamage and at least 3 actinic keratosis on the face

Exclusion Criteria:

  • Pregnancy, laser, chemical peel, imiquimod or 5-Fu treatment in the last year

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): NCT00843323

Sponsors and Collaborators
University of Sao Paulo
University of Regensburg
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Principal Investigator: Luis A Torezan, MD Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
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Responsible Party: Luis Antonio R. Torezan, Hospital das Clinicas Universidade Sao Paulo Identifier: NCT00843323    
Other Study ID Numbers: 0614/08
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents