BurnsNCT03240718
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
A study testing Laser treatment in people with Burns, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial summary
This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Burns
- What is being tested?
- Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick skin type <IV (37),
- Have sustained a thermal burn injury,
- Have at least 2 independent sites that show clinical evidence of HSc,
- Are 2 months or more post-injury.
Who cannot join
- Subjects with skin phototypes IV or higher,
- With history of keloidal scarring,
- Who have coagulation disorder,
- Are taking immunosuppressive medications,
- If the mechanism of injury is an electrical, chemical, or cold injury,
- Any underlying active skin disease,
Show all 10Show fewer
- Have taken oral Isotreinoin within the last 6 months,
- Photosensitivity or have taken photosensitizing medications,
- Pregnancy,
- Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment
About this study
Official title: Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.
Read the detailed description
Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.
- Conditions
- Burns
- Being tested
- Laser treatment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentProcedure or surgery
CORE fractional CO2 laser treatment
| Study group | Role | What they receive |
|---|---|---|
| Laser treated HSc scar | Experimental | Co2 laser treatment Receives: Procedure: Laser treatment |
| Control scar | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Characteristics changes
Erythema, elasticity and thickness measures
Measured: baseline, 12 weeks and 24 weeks
Secondary outcomes (1)
Satisfaction Questionnaire
Questionnaire
Measured: baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startFeb 2015
- Primary completionMay 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette Nedelec, PhD, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240718
- Sponsor's protocol ID
- CE14-122
- Status last verified
- Dec 2015
- First submitted
- 3 Feb 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
- ClinicalTrials.gov ID
- NCT03240718
- Acronym / sponsor ID
- CE14-122
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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.
This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.
Detailed description
Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treated HSc scar | Experimental | Procedure: Laser treatmentCo2 laser treatment |
| Control scar | No intervention | –Standard care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fitzpatrick skin type <IV (37),
- Have sustained a thermal burn injury,
- Have at least 2 independent sites that show clinical evidence of HSc,
- Are 2 months or more post-injury.
Key exclusion criteria (10 listed)
- Subjects with skin phototypes IV or higher,
- With history of keloidal scarring,
- Who have coagulation disorder,
- Are taking immunosuppressive medications,
- If the mechanism of injury is an electrical, chemical, or cold injury,
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 |
|---|---|---|
| Laser treatmentCORE fractional CO2 laser treatment | Procedure or surgery | Laser treated HSc scar |
Primary outcome
Skin Characteristics changes
Time frame: baseline, 12 weeks and 24 weeks
Erythema, elasticity and thickness measures
1 secondary outcome
Satisfaction Questionnaire
Time frame: baseline, 24 weeks
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 17 Aug 2017.
- Individual participant dataSharing planned: Yes
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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.
Bernadette Nedelec, PhD principal investigator
CRCHUM
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Burns, run by Centre hospitalier de l'Université de Montréal (CHUM).
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 10 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Skin Characteristics changes (time frame: baseline, 12 weeks and 24 weeks). 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 17 Aug 2017.