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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
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 12, 2009
    Last Updated
    May 8, 2023
    Sponsor
    University of Sao Paulo
    Collaborators
    University of Regensburg
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    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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