Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT
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,
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Luis A Torezan, MD
Principal Investigator
Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
Brazil: Ethics Committee
0614/08
NCT00843323
December 2008
June 2009
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