Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin

This study has been completed.
Sponsor:
Collaborator:
University of Regensburg
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00843323
First received: February 12, 2009
Last updated: June 10, 2010
Last verified: June 2010
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 12, 2009
Last Updated: June 10, 2010
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Methyl 5-aminolevulinate
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014