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

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Actinic Keratosis, Photoaging, Solar Elastosis

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Trial Information

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


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,

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Luis A Torezan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil


Brazil: Ethics Committee

Study ID:




Start Date:

December 2008

Completion Date:

June 2009

Related Keywords:

  • Actinic Keratosis
  • Photoaging
  • Solar Elastosis
  • Keratosis
  • Keratosis, Actinic
  • Skin Diseases