Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Photoaging Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases Solar Elastosis

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylaminolevulinate - photodynamic therapy

Other

Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

University of Regensburg

Registry information

Official study title

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

Acronym: PDT

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Feb 13, 2009
Registry last updated: May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed