ScarPhase 1NCT01005992
Fractional Photothermolysis for the Treatment of Burn Scars
A Phase 1 study testing Fractional laser treatment and Standard scar management in people with Scar, run by Clinica las Condes, Chile at 1 site in Chile.
Trial summary
The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Scar
- What is being tested?
- Fractional laser treatment and Standard scar management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- Nov 2009to Apr 2010
- Phase
- Phase 1
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution.
- The scar should be slightly elevated, with erythema and with no signs of keloid formation.
- Maximum scar dimension: 0.2 - 1% body surface area.
- Acceptance of informed consent for laser treatment.
Who cannot join
- Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc).
- Previous surgical treatment (i.e. graft)
Trial locations and contacts
1 site in 1 country.
Chile1 site
Clinica Las Condes
Santiago, RM
Rodrigo J Schwartz, MD, 56-2-6108661
Fresia Solias, investigacion@coaniquem.cl
About this study
The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.
Read the detailed description
One of the main problems in the management of burned patients is the treatment of post-burn scarring. Frequently this scars cover large areas, tend to retract, present pigmentary changes and are disfiguring, producing significant life quality impairment.
Unfortunately, there are very few therapeutic options for treating these scars, which can be secondary to reconstructive surgery or after spontaneous healing. In the last decades most reports in scar treatment have included, pressure garments, chemical peeling, dermabrasion, ablative and non-ablative laser therapy and surgery with varying degrees of success. There is only one report treating burn scars with fractional laser, with good results.
The aim of our study is to determine the effect of of a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc.) in the treatment of burn scars.
- Conditions
- Scar
- Being tested
- Fractional laser treatment, Standard scar management
- Keywords
- Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional laser treatmentProcedure or surgery
A complete treatment will consist in four laser sessions with a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc at 1-month intervals. Treatment will be delivered with a 15-mm tip and concomitant air-cooling system (Zimmer MedizinSystems, Irvine, CA). Fluence and treatment level will be registered on every session and will be adjusted according to patient tolerance.
Standard scar managementProcedure or surgery
The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.
| Study group | Role | What they receive |
|---|---|---|
| Laser treated scar | Experimental | The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities. Receives: Procedure: Fractional laser treatment |
| Standard scar management | Active comparator | The standard scar management arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities. Receives: Procedure: Standard scar management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.
Measured: 5 months
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation
Measured: 5 months
Secondary outcomes (3)
Change in surface area and perimeter of burn scar
Measured: 5 months
Tissue pliability, elevation and flexibility with a digital piedemeter
Measured: 5 months
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ScarStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica las Condes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion de ayuda al niño quemado (COANIQUEM), Solta Medical
- Investigators
- Rodrigo J Schwartz, MD, Principal investigator, Clinica Las Condes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005992
- Sponsor's protocol ID
- CLCCQFQ-1
- Status last verified
- Oct 2009
- First submitted
- 30 Oct 2009
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Dermatol Surg. 2008 Oct;34(10):1327-32. doi: 10.1111/j.1524-4725.2008.34284.x.
PubMed 19040687Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4. doi: 10.1111/j.1524-4725.2007.33058.x.
PubMed 17338685Haedersdal M. Fractional ablative CO(2) laser resurfacing improves a thermal burn scar. J Eur Acad Dermatol Venereol. 2009 Nov;23(11):1340-1. doi: 10.1111/j.1468-3083.2009.03215.x. Epub 2009 Mar 4. No abstract available.
PubMed 19309424Haedersdal M, Moreau KE, Beyer DM, Nymann P, Alsbjorn B. Fractional nonablative 1540 nm laser resurfacing for thermal burn scars: a randomized controlled trial. Lasers Surg Med. 2009 Mar;41(3):189-95. doi: 10.1002/lsm.20756.
PubMed 19291747Waibel J, Beer K. Fractional laser resurfacing for thermal burns. J Drugs Dermatol. 2008 Jan;7(1):59-61.
PubMed 18246699Waibel J, Beer K. Ablative fractional laser resurfacing for the treatment of a third-degree burn. J Drugs Dermatol. 2009 Mar;8(3):294-7.
PubMed 19271380
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Photothermolysis for the Treatment of Burn Scars
- ClinicalTrials.gov ID
- NCT01005992
- Acronym / sponsor ID
- CLCCQFQ-1
- Conditions
- Scar
- Keywords
- Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Clinica las Condes, ChileUniversity, hospital or other
- Collaborators
- Corporacion de ayuda al niño quemado (COANIQUEM), Solta Medical
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (estimated)
- First posted
- 2 Nov 2009 (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 aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.
Detailed description
One of the main problems in the management of burned patients is the treatment of post-burn scarring. Frequently this scars cover large areas, tend to retract, present pigmentary changes and are disfiguring, producing significant life quality impairment.
Unfortunately, there are very few therapeutic options for treating these scars, which can be secondary to reconstructive surgery or after spontaneous healing. In the last decades most reports in scar treatment have included, pressure garments, chemical peeling, dermabrasion, ablative and non-ablative laser therapy and surgery with varying degrees of success. There is only one report treating burn scars with fractional laser, with good results.
The aim of our study is to determine the effect of of a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc.) in the treatment of burn scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treated scar | Experimental | Procedure: Fractional laser treatmentThe standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities. |
| Standard scar management | Active comparator | Procedure: Standard scar managementThe standard scar management arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution.
- The scar should be slightly elevated, with erythema and with no signs of keloid formation.
- Maximum scar dimension: 0.2 - 1% body surface area.
- Acceptance of informed consent for laser treatment.
Key exclusion criteria (2 listed)
- Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc).
- Previous surgical treatment (i.e. graft)
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 |
|---|---|---|
| Fractional laser treatmentA complete treatment will consist in four laser sessions with a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc at 1-month intervals. Treatment will be delivered with a 15-mm tip and concomitant air-cooling system (Zimmer MedizinSystems, Irvine, CA). Fluence and treatment level will be registered on every session and will be adjusted according to patient tolerance. | Procedure or surgery | Laser treated scar |
| Standard scar managementThe standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities. | Procedure or surgery | Standard scar management |
Primary outcome
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.
Time frame: 5 months
Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation
Time frame: 5 months
3 secondary outcomes
Change in surface area and perimeter of burn scar
Time frame: 5 months
Tissue pliability, elevation and flexibility with a digital piedemeter
Time frame: 5 months
Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
- Background: PubMed 19040687Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Dermatol Surg. 2008 Oct;34(10):1327-32. doi: 10.1111/j.1524-4725.2008.34284.x.
- Background: PubMed 17338685Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4. doi: 10.1111/j.1524-4725.2007.33058.x.
- Background: PubMed 19309424Haedersdal M. Fractional ablative CO(2) laser resurfacing improves a thermal burn scar. J Eur Acad Dermatol Venereol. 2009 Nov;23(11):1340-1. doi: 10.1111/j.1468-3083.2009.03215.x. Epub 2009 Mar 4. No abstract available.
- Background: PubMed 19291747Haedersdal M, Moreau KE, Beyer DM, Nymann P, Alsbjorn B. Fractional nonablative 1540 nm laser resurfacing for thermal burn scars: a randomized controlled trial. Lasers Surg Med. 2009 Mar;41(3):189-95. doi: 10.1002/lsm.20756.
- Background: PubMed 18246699Waibel J, Beer K. Fractional laser resurfacing for thermal burns. J Drugs Dermatol. 2008 Jan;7(1):59-61.
- Background: PubMed 19271380Waibel J, Beer K. Ablative fractional laser resurfacing for the treatment of a third-degree burn. J Drugs Dermatol. 2009 Mar;8(3):294-7.
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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.
Rodrigo J Schwartz, MD principal investigator
Clinica Las Condes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fractional laser treatment and Standard scar management in people with Scar, run by Clinica las Condes, Chile at 1 site in Chile.
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 2 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 2 Nov 2009. 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 Chile. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Rodrigo Schwartz, MD (56-2-6108661, schwartz.rodrigo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography. (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005992, which also lists 6 linked publications.
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 2 Nov 2009.