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
20 participants
INTERVENTIONAL
2012-01-31
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn scars after NAFL-treatment.
HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and functional appearance.
METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment Scale; 1 = normal skin, 10 = worst imaginable scar).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
One area assessed as a control area, compared to the laser-treated area
non-ablative fractional laser
3 treatments with 4-6 weeks interval
Non-ablative Laser treatment
3 Non-ablative fractional laser treatments of one area
control
observation, comparison to laser-treated area
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
non-ablative fractional laser
3 treatments with 4-6 weeks interval
control
observation, comparison to laser-treated area
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Fitzpatrick skin type I-III
* burn scar 1 year or older
* total scar area allowing selection of two similar side-by-side test areas of minimum 1.5 × 3 cm for study purpose
Exclusion Criteria
* suntan
* wounds or infections in study area
* tendency to form hypertrophic scars or keloids
* oral retinoids, anti-inflammatory or immunosuppressive drugs within the last six months
* current anticoagulants
* previous treatments in test area with laser, Intense Pulsed Light, dermabrasion, chemical peel or filler.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bispebjerg Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elisabeth Taudorf
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Merete Hædersdal, MD,PhD,DmSc
Role: STUDY_DIRECTOR
Bispebjerg Hospital, University of Copenhagen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bispebjerg Hospital, University of Copenhagen
Copenhagen NV, Copenhagen, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H3-2009-149
Identifier Type: -
Identifier Source: org_study_id