- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00843323
Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin (PDT)
Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT
Study Overview
Status
Conditions
Intervention / Treatment
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,
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Luis A Torezan, MD, Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0614/08
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