NCT00843323

Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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,

Conditions

• Actinic Keratosis
• Photoaging
• Solar Elastosis

Interventions

Type	Name	Description
OTHER	Methylaminolevulinate - photodynamic therapy	Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-03-01
• Completion: 2009-06-01
• First posted: 2009-02-13
• Last updated: 2023-05-10