Burn ScarsNCT02014298
Non Ablative Fractional Laser Treatment of Burn Scars
A study testing non-ablative fractional laser in people with Burn Scars, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars. OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn scars after NAFL-treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Scars
- What is being tested?
- non-ablative fractional laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- legally competent adults aged 18-60 years
- 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
Who cannot join
- pregnancy or lactation
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, University of Copenhagen
Copenhagen NV, Copenhagen, DK-2400
About this study
Official title: LONG-TERM AND CONTINUED IMPROVEMENT OF MATURE BURN SCARS IN RESPONSE TO NONABLATIVE FRACTIONAL LASER - A RANDOMIZED CONTROLLED TRIAL WITH HISTOLOGICAL EVALUATION
BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars.
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).
- Conditions
- Burn Scars
- Being tested
- non-ablative fractional laser, control
- Keywords
- Burns, Non-ablative fractional laser, scar texture, histology, laser treatment, erbium:glass laser, meshed skin-grafts, photothermolysis, skin
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-ablative fractional laserRadiation
Also called non-ablative fractional er:glass laser, 1,540 nm laser treatment
3 treatments with 4-6 weeks interval
controlOther
Also called observation
observation, comparison to laser-treated area
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | One area assessed as a control area, compared to the laser-treated area Receives: Radiation: non-ablative fractional laser |
| Non-ablative Laser treatment | Active comparator | 3 Non-ablative fractional laser treatments of one area Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall Scar-appearance
Primary endpoint is change in overall scar-appearance assessed by a slightly modified Patient and Observer Scar Assessment Scale (evaluation of study area omitted since this is fixed as part of study procedure). Scale: 1= normal skin; 10= worst imaginable scar.
Measured: 1,3 and 6 months follow-up
Secondary outcomes (1)
specific clinical and histological scar appearance
Additional assessments include:
- evaluation of vascularity, pigmentation, thickness, relief, pliability (evaluated on modified Patient and Observer Scar Assessment Scale)
- histological changes (Small safety issue from taking a 4 mm cutaneous punch biopsy)
- patient satisfaction
- adverse events (pain during treatment, immediate treatment reaction, 24h treatment reaction, evaluation of side effects at 6 months follow-up)
Measured: 1, 3, and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Taudorf, Bispebjerg Hospital
- Investigators
- Merete Hædersdal, MD,PhD,DmSc, Study director, Bispebjerg Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014298
- Sponsor's protocol ID
- H3-2009-149
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LONG-TERM AND CONTINUED IMPROVEMENT OF MATURE BURN SCARS IN RESPONSE TO NONABLATIVE FRACTIONAL LASER - A RANDOMIZED CONTROLLED TRIAL WITH HISTOLOGICAL EVALUATION
- ClinicalTrials.gov ID
- NCT02014298
- Acronym / sponsor ID
- H3-2009-149
- Conditions
- Burn Scars
- Keywords
- Burns, Non-ablative fractional laser, scar texture, histology, laser treatment, erbium:glass laser, meshed skin-grafts, photothermolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Radiation: non-ablative fractional laserOne area assessed as a control area, compared to the laser-treated area |
| Non-ablative Laser treatment | Active comparator | Other: control3 Non-ablative fractional laser treatments of one area |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- legally competent adults aged 18-60 years
- 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
Key exclusion criteria (7 listed)
- pregnancy or lactation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-ablative fractional laserAlso: non-ablative fractional er:glass laser, 1,540 nm laser treatment3 treatments with 4-6 weeks interval | Radiation | Control |
| controlAlso: observationobservation, comparison to laser-treated area | Other | Non-ablative Laser treatment |
Primary outcome
Change in overall Scar-appearance
Time frame: 1,3 and 6 months follow-up
Primary endpoint is change in overall scar-appearance assessed by a slightly modified Patient and Observer Scar Assessment Scale (evaluation of study area omitted since this is fixed as part of study procedure). Scale: 1= normal skin; 10= worst imaginable scar.
1 secondary outcome
specific clinical and histological scar appearance
Time frame: 1, 3, and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
Related trials for Burn Scars
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingPhase 3
Novel Strategies for Reducing Burn Scar Itch
Burn Scar, Itch Scarring
RecruitingPhase 2/3
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Burn Scar, Burn Wound
Not yet recruiting
Tools for Return of Facial Function
Facial Scarring, Facial Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Hædersdal, MD,PhD,DmSc study director
Bispebjerg Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-ablative fractional laser in people with Burn Scars, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall Scar-appearance (time frame: 1,3 and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.