ScarsNCT01358838
Ablative 10600 nm Fractional Laser Therapy for the Treatment of Scars
A study testing ablative 10600 nm fractional laser therapy in people with Scars, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Scars can be highly disfiguring and may result in functional impairment and psychosocial problems. Recently, fractional laser therapy (FLT) has been introduced as a promising novel treatment modality for scars. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- ablative 10600 nm fractional laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Atrophic or hypertrophic scars allowing for demarcation of two similar test regions of at least 2x2cm
- Age at least 18 years
- Subject is willing and able to give written informed consent
- Interval between injury and start of study at least one year
Who cannot join
- Suspected allergy to lidocaine
- Use of roaccutane (isotretinoin) in the past 12 months
- Subjects not competent to understand what is involved
- Skin type V and VI
- Pregnancy
- Concomitant skin disease at the site of treatment
- Presence of lesions suspicious for malignancy in the scar
- High exposure to sunlight (vacation in southern countries) or UV light (UVA or UVB) during the first 4 weeks after treatment
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
The Netherlands Institute for Pigment Disorders
Amsterdam
About this study
Official title: Ablative 10600 nm Fractional Laser Therapy for the Treatment of Scars; a Randomized Controlled Trial
Rationale: Scars can be highly disfiguring and may result in functional impairment and psychosocial problems. Recently, fractional laser therapy (FLT) has been introduced as a promising novel treatment modality for scars.
Objectives: The primary objective of this study is to assess the efficacy and safety of 10600 nm FLT for the treatment of different types of scars.
Read more
Study design: Prospective observer blinded randomised controlled split-lesion trial.
Study population: Thirty consecutive patients, aged at least 18 years, with hypertrophic or atrophic scars who give written informed consent.
Methods: Two similar test regions of the scar will be randomly allocated to either 3 sessions of FLT (UltraPulse Encore 10600 nm Total FX) with an interval of 4 weeks or no treatment.
Main study parameters/endpoints: Blinded Physicians Global Assessment is the main outcome variable. Secondary variables are Patient's Global Assessment, blinded clinical assessment of the scar on a scale from 0-3 (erythema, pigmentation, texture, hypertrophy, atrophy, pliability), Patient and Observer Scar Scale (POSAS), objective colour measurements by reflectance spectroscopy (LAB) and chromameter (erythema index, melanin index).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects participating in the study will be requested to visit the SNIP (Amsterdam) 3 times for treatment and 2 times for follow-up. The time investment per visit will be 30 minutes for treatment sessions and 20 minutes for follow-up visits. FLT using a 10600 nm laser device is a minimally invasive laser procedure with FDA approval for both the device (Lumenis Encore 10600 nm) and the indication (scar). Local side effects are erythema (always; 1-2 weeks), oozing (often; 1-3 days), swelling (always, 1-4 days), blisters < 0.5cm (occasionally) and blisters > 0.5cm (very rare). No systemic side effects are known for this laser device.
All outcome measures involve non-invasive procedures. The laser treatment (FLT) requires local anesthesia. The amount of topical anesthetic used for infiltration is low (approximately 5% of the maximum dose) which minimizes the risk for local or systemic side effects due to the anesthetic agent.
All together the burden due to the study is moderate, side effects are generally local and mild. Systemic side effects are not reported with this treatment. There is an indirect benefit for the participating subject. In case of improvement of the treated test regions, this therapy can be directly utilized to treat the whole scar.
Considering the relative lack of alternative treatment options in many of these scars, the balance between burden, possible side effects and prospect for improvement is very favorable.
- Conditions
- Scars
- Being tested
- ablative 10600 nm fractional laser therapy
- Keywords
- Patients with either hypertrophic or atrophic scars, Efficacy of ablative 10600nm fractional laser therapy, Laser therapy compared to no treatment of (part of) the scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablative 10600 nm fractional laser therapyDevice
Half of the scar, or one of two comparable scars, will be treated with the ablative 10600 nm fractional laser. There wil be 3 treatments, with 8 weeks apart.
Half of the scar, or one of two comparable scars, will receive no treatment at all.
| Study group | Role | What they receive |
|---|---|---|
| laser | Active comparator | Not described Receives: Device: ablative 10600 nm fractional laser therapy |
| no laser | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the scar
Improvement of erythema, pigment, and structure of the scar assessed by a blinded dermatologist (blinded physician global assessment) and by objective colour measurements (chromameter)
Measured: 18 months
Secondary outcomes (1)
Patients satisfaction
Improvement of the scar assessed by the patient(Patient's global assessment)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)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
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358838
- Sponsor's protocol ID
- METC 10/026
- Status last verified
- May 2010
- First submitted
- 19 May 2011
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablative 10600 nm Fractional Laser Therapy for the Treatment of Scars; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01358838
- Acronym / sponsor ID
- METC 10/026
- Conditions
- Scars
- Keywords
- Patients with either hypertrophic or atrophic scars, Efficacy of ablative 10600nm fractional laser therapy, Laser therapy compared to no treatment of (part of) the scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 May 2011 (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.
Rationale: Scars can be highly disfiguring and may result in functional impairment and psychosocial problems. Recently, fractional laser therapy (FLT) has been introduced as a promising novel treatment modality for scars.
Objectives: The primary objective of this study is to assess the efficacy and safety of 10600 nm FLT for the treatment of different types of scars.
Study design: Prospective observer blinded randomised controlled split-lesion trial.
Study population: Thirty consecutive patients, aged at least 18 years, with hypertrophic or atrophic scars who give written informed consent.
Methods: Two similar test regions of the scar will be randomly allocated to either 3 sessions of FLT (UltraPulse Encore 10600 nm Total FX) with an interval of 4 weeks or no treatment.
Main study parameters/endpoints: Blinded Physicians Global Assessment is the main outcome variable. Secondary variables are Patient's Global Assessment, blinded clinical assessment of the scar on a scale from 0-3 (erythema, pigmentation, texture, hypertrophy, atrophy, pliability), Patient and Observer Scar Scale (POSAS), objective colour measurements by reflectance spectroscopy (LAB) and chromameter (erythema index, melanin index).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects participating in the study will be requested to visit the SNIP (Amsterdam) 3 times for treatment and 2 times for follow-up. The time investment per visit will be 30 minutes for treatment sessions and 20 minutes for follow-up visits. FLT using a 10600 nm laser device is a minimally invasive laser procedure with FDA approval for both the device (Lumenis Encore 10600 nm) and the indication (scar). Local side effects are erythema (always; 1-2 weeks), oozing (often; 1-3 days), swelling (always, 1-4 days), blisters < 0.5cm (occasionally) and blisters > 0.5cm (very rare). No systemic side effects are known for this laser device.
All outcome measures involve non-invasive procedures. The laser treatment (FLT) requires local anesthesia. The amount of topical anesthetic used for infiltration is low (approximately 5% of the maximum dose) which minimizes the risk for local or systemic side effects due to the anesthetic agent.
All together the burden due to the study is moderate, side effects are generally local and mild. Systemic side effects are not reported with this treatment. There is an indirect benefit for the participating subject. In case of improvement of the treated test regions, this therapy can be directly utilized to treat the whole scar.
Considering the relative lack of alternative treatment options in many of these scars, the balance between burden, possible side effects and prospect for improvement is very favorable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser | Active comparator | Device: ablative 10600 nm fractional laser therapy |
| no laser | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Atrophic or hypertrophic scars allowing for demarcation of two similar test regions of at least 2x2cm
- Age at least 18 years
- Subject is willing and able to give written informed consent
- Interval between injury and start of study at least one year
Key exclusion criteria (8 listed)
- Suspected allergy to lidocaine
- Use of roaccutane (isotretinoin) in the past 12 months
- Subjects not competent to understand what is involved
- Skin type V and VI
- Pregnancy
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 |
|---|---|---|
| ablative 10600 nm fractional laser therapyHalf of the scar, or one of two comparable scars, will be treated with the ablative 10600 nm fractional laser. There wil be 3 treatments, with 8 weeks apart. Half of the scar, or one of two comparable scars, will receive no treatment at all. | Device | laser |
Primary outcome
Improvement of the scar
Time frame: 18 months
Improvement of erythema, pigment, and structure of the scar assessed by a blinded dermatologist (blinded physician global assessment) and by objective colour measurements (chromameter)
1 secondary outcome
Patients satisfaction
Time frame: 18 months
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 7 Feb 2013.
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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 ablative 10600 nm fractional laser therapy in people with Scars, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 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: finished, as of the sponsor's last update on 7 Feb 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 Netherlands. 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?
Improvement of the scar (time frame: 18 months). 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 7 Feb 2013.