We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00843323
First Posted: February 13, 2009
Last Update Posted: June 11, 2010
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.
Collaborator:
University of Regensburg
Information provided by:
University of Sao Paulo
  Purpose
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 Intervention
Actinic Keratosis Photoaging Solar Elastosis Other: Methylaminolevulinate - photodynamic therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Enrollment: 26
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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
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

Evaluation:

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,

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00843323


Sponsors and Collaborators
University of Sao Paulo
University of Regensburg
Investigators
Principal Investigator: Luis A Torezan, MD Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
  More Information

Responsible Party: Luis Antonio R. Torezan, Hospital das Clinicas Universidade Sao Paulo
ClinicalTrials.gov Identifier: NCT00843323     History of Changes
Other Study ID Numbers: 0614/08
First Submitted: February 12, 2009
First Posted: February 13, 2009
Last Update Posted: June 11, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Methyl 5-aminolevulinate
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents