Burn Scar PatientsNCT00689650
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial
A study testing 1540 nm fractional laser in people with Burn Scar Patients, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature burn scars. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Scar Patients
- What is being tested?
- 1540 nm fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to not given
- 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
- Burn scars with and without previous skin grafting.
Who cannot join
- A tendency to produce hypertrophic scars or keloids,
- Previous treatment with dermabrasio, chemical peel, filler, laser treatment or Intense Pulsed Light (IPL) of study areas,
- Photosensitivity,
- Pregnancy or lactation,
- Current anticoagulative medication,
- Oral retinoid drugs within the past 6 months,
- Pigmentation after recent exposure to sun or solarium,
- Patients not considered to be able to follow the treatment protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature burn scars.
- Conditions
- Burn Scar Patients
- Being tested
- 1540 nm fractional laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1540 nm fractional laserDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: 1540 nm fractional laser |
| B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of skin texture from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Scar PatientsStudies 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
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689650
- Sponsor's protocol ID
- H-D-2007-0094
- Status last verified
- May 2008
- First submitted
- 30 May 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00689650
- Acronym / sponsor ID
- H-D-2007-0094
- Conditions
- Burn Scar Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Nov 2007
- First posted
- 3 Jun 2008 (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.
The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature burn scars.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: 1540 nm fractional laser |
| B | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Burn scars with and without previous skin grafting.
Key exclusion criteria (8 listed)
- A tendency to produce hypertrophic scars or keloids,
- Previous treatment with dermabrasio, chemical peel, filler, laser treatment or Intense Pulsed Light (IPL) of study areas,
- Photosensitivity,
- Pregnancy or lactation,
- Current anticoagulative medication,
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 |
|---|---|---|
| 1540 nm fractional laser | Device | A |
Primary outcome
Change of skin texture from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1540 nm fractional laser in people with Burn Scar Patients, 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jun 2008. 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?
Results are not available in the source record.
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 of skin texture from baseline. 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 3 Jun 2008.