Skip to content

Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00843323
Acronym
PDT
Enrollment
26
Registered
2009-02-13
Start date
2008-12-31
Completion date
2009-06-30
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis, Photoaging, Solar Elastosis

Brief 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,

Interventions

OTHERMethylaminolevulinate - photodynamic therapy

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

Sponsors

University of Regensburg
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026