Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin
NCT ID: NCT00843323
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
26 participants
INTERVENTIONAL
2008-12-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Daylight-PDT With MAL for AK and Photodamaged Skin
NCT02736760
Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL
NCT02149342
Treatment of Actinic Keratoses With Photodynamic Therapy Using Sunlight Versus Red Light
NCT00432224
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
NCT03013647
Transepidermal Application of Metilaminolevulinate in Daylight PDT in the Treatment of Photodamaged Skin
NCT03963765
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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,
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methylaminolevulinate - photodynamic therapy
Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
20 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Regensburg
OTHER
University of Sao Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luis Antonio Torezan
ASSOCIATE PROFESSOR OF DERMATOLOGY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luis A Torezan, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital das Clinicas - Faculdade de Medicina USP - Sao Paulo- Brazil
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0614/08
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.