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NCT00843323 Clinical Trial

Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin

Actinic Keratosis Clinical Trial

— PDT  

Official title:
Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00843323
Other study ID # 0614/08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2008
Est. completion date June 2009

Study information
Verified date May 2023
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date June 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Sao Paulo University of Regensburg
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