Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin (PDT)
Primary Purpose
Actinic Keratosis, Photoaging, Solar Elastosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Methylaminolevulinate - photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00843323
First Posted
February 12, 2009
Last Updated
May 8, 2023
Sponsor
University of Sao Paulo
Collaborators
University of Regensburg
1. Study Identification
Unique Protocol Identification Number
NCT00843323
Brief Title
Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin
Acronym
PDT
Official Title
Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
University of Regensburg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis, Photoaging, Solar Elastosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Methylaminolevulinate - photodynamic therapy
Intervention Description
Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Torezan, MD
Organizational Affiliation
Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin
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