ScarsPhase 4NCT01056211
1540nm Non Ablative Fractional Laser Treatment of Scars
A Phase 4 study testing laser treatment and treatment without laser in people with Scars, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect can play a key role in patient satisfaction and self-image. Non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scars
- What is being tested?
- laser treatment and treatment without laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to Aug 2013
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a hypopigmented scar allowing 2 side by side test areas of similar sizes and appearance within the same anatomical region.
- Skin type 1-4
- Age at least 18 years old
- Willingness and ability to give written informed consent and to comply with the requirements of the protocol
- Patients with a hypertrophic scar allowing 2 side by site test areas of similar sizes and appearance within the same anatomical region.
- Skin type 1-4
Show all 13Show fewer
- Male / Female
- Age at least 18 years old
- Willingness and ability to give written informed consent and to comply with the requirements of the protocol
- Patients with a graft or reconstruction with 2 site by site test areas of similar sizes and appearance within the same anatomical region (head and neck region).
- Skin type 1-4
- Age at least 18 years old
- Willingness and ability to give written informed consent and to comply with the requirements of the protocol
Who cannot join
- Pregnancy and lactation
- Oral retinoid drugs within the past 6 months
- Patientgroup 2: patients with hypertrophic scars :
- Pregnancy and lactation
- Oral retinoid drugs within the past 6 months
- Patient group 3: Patients with scars due to grafts and reconstructions in the head and neck region.
- Pregnancy and lactation
- Oral retinoid drugs within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.
Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect can play a key role in patient satisfaction and self-image.
Non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound healing response. There are different reports on the positive effect of these type of laser treatment in the treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars.
Read more
The low morbidity of the treatment and the lack of satisfying treatment regimes for different types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with the 1540nm non ablative fractional laser in the treatment of scars.
Objectives:
- To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser treatment for 3 different "scar" patient groups :
- Patients with hypopigmented scars
- Patients with hypertrophic scars
- Patients with scars due to grafts and reconstructions in the head and neck region.
- To evaluate the treatment related pain. on a categorical scale from 0-10
- To evaluate the adverse effect of 1540nm fractional laser versus untreated control in the 3 patient groups.
The study design is a prospective single blinded randomised within-patient controlled study The study involves 6 visits.
- Conditions
- Scars
- Being tested
- laser treatment, treatment without laser
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treatmentProcedure or surgery
Starlux 300 Lux 1540nm Fractional laser hand piece
treatment without laserProcedure or surgery
Starlux 300 Lux 1540nm Fractional laser hand piece
laser treatmentProcedure or surgery
Starlux 300 Lux 1540nm Fractional laser hand piece
| Study group | Role | What they receive |
|---|---|---|
| hypopigmented scars treated with laser | Active comparator | patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece Receives: Procedure: laser treatment |
| hypopigmented scars treated without laser | Placebo comparator | patients with hypopigmented scars treated without laser Receives: Procedure: treatment without laser |
| hypertrophic scars treated with laser | Active comparator | Not described Receives: Procedure: laser treatment |
| hypertrophic scars not treated with laser | Placebo comparator | Not described Receives: Procedure: treatment without laser |
| scars due to grafts and reconstructions treated with laser | Active comparator | scars due to grafts and reconstructions in the head and neck region Receives: Procedure: laser treatment |
| grafts and reconstructions scars not treated with laser | Placebo comparator | scars due to grafts and reconstructions in the head and neck region Receives: Procedure: treatment without laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional handpiece (Palomar Medical Technologies) 1 and 3 months after the last laser treatment in 3 different "scar" patient groups
Measured: at 1 and 3 months
Evaluation of the treatment related pain
Measured: at 1 and 3 months
Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site
Measured: at 1 and 3 months
Secondary outcomes (6)
Evaluation of skin redness and pigmentation
Measured: at 1 and 3 months after treatment
Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment
Measured: at 1 and 3 months after treatment
Physician assessment for the treated and control region (PhGA)
Measured: at 1 and 3 months after treatment
patient assessment for the treated and control region
Measured: at 1 and 3 months after treatment
Photografic documentation of scar improvement
Measured: at 1 and 3 months after treatment
Evaluation of histological difference in treated an non treated parts of the scar
Measured: at 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2013
- Study completionAug 2013
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 University Hospital, GhentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelien Verhaeghe, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056211
- Sponsor's protocol ID
- 2009/626
- Status last verified
- Dec 2014
- First submitted
- 25 Jan 2010
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.
- ClinicalTrials.gov ID
- NCT01056211
- Acronym / sponsor ID
- 2009/626
- Conditions
- Scars
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Jan 2010 (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.
Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect can play a key role in patient satisfaction and self-image.
Non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound healing response. There are different reports on the positive effect of these type of laser treatment in the treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars.
The low morbidity of the treatment and the lack of satisfying treatment regimes for different types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with the 1540nm non ablative fractional laser in the treatment of scars.
Objectives:
- To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser treatment for 3 different "scar" patient groups :
- Patients with hypopigmented scars
- Patients with hypertrophic scars
- Patients with scars due to grafts and reconstructions in the head and neck region.
- To evaluate the treatment related pain. on a categorical scale from 0-10
- To evaluate the adverse effect of 1540nm fractional laser versus untreated control in the 3 patient groups.
The study design is a prospective single blinded randomised within-patient controlled study The study involves 6 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| hypopigmented scars treated with laser | Active comparator | Procedure: laser treatmentpatients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece |
| hypopigmented scars treated without laser | Placebo comparator | Procedure: treatment without laserpatients with hypopigmented scars treated without laser |
| hypertrophic scars treated with laser | Active comparator | Procedure: laser treatment |
| hypertrophic scars not treated with laser | Placebo comparator | Procedure: treatment without laser |
| scars due to grafts and reconstructions treated with laser | Active comparator | Procedure: laser treatmentscars due to grafts and reconstructions in the head and neck region |
| grafts and reconstructions scars not treated with laser | Placebo comparator | Procedure: treatment without laserscars due to grafts and reconstructions in the head and neck region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with a hypopigmented scar allowing 2 side by side test areas of similar sizes and appearance within the same anatomical region.
- Skin type 1-4
- Age at least 18 years old
- Willingness and ability to give written informed consent and to comply with the requirements of the protocol
- Patients with a hypertrophic scar allowing 2 side by site test areas of similar sizes and appearance within the same anatomical region.
Key exclusion criteria (8 listed)
- Pregnancy and lactation
- Oral retinoid drugs within the past 6 months
- Pregnancy and lactation
- Oral retinoid drugs within the past 6 months
- Patient group 3: Patients with scars due to grafts and reconstructions in the head and neck region.
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 treatmentStarlux 300 Lux 1540nm Fractional laser hand piece | Procedure or surgery | hypertrophic scars treated with laser, hypopigmented scars treated with laser, scars due to grafts and reconstructions treated with laser |
| treatment without laserStarlux 300 Lux 1540nm Fractional laser hand piece | Procedure or surgery | grafts and reconstructions scars not treated with laser, hypertrophic scars not treated with laser, hypopigmented scars treated without laser |
| laser treatmentStarlux 300 Lux 1540nm Fractional laser hand piece | Procedure or surgery | scars due to grafts and reconstructions treated with laser |
Primary outcome
efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional handpiece (Palomar Medical Technologies) 1 and 3 months after the last laser treatment in 3 different "scar" patient groups
Time frame: at 1 and 3 months
Evaluation of the treatment related pain
Time frame: at 1 and 3 months
Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site
Time frame: at 1 and 3 months
6 secondary outcomes
Evaluation of skin redness and pigmentation
Time frame: at 1 and 3 months after treatment
Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment
Time frame: at 1 and 3 months after treatment
Physician assessment for the treated and control region (PhGA)
Time frame: at 1 and 3 months after treatment
patient assessment for the treated and control region
Time frame: at 1 and 3 months after treatment
Photografic documentation of scar improvement
Time frame: at 1 and 3 months after treatment
Evaluation of histological difference in treated an non treated parts of the scar
Time frame: at 3 months after treatment
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 5 Dec 2014.
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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.
Evelien Verhaeghe, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing laser treatment and treatment without laser in people with Scars, run by University Hospital, Ghent at 1 site in Belgium.
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 13 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 5 Dec 2014. 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 Belgium. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional handpiece (Palomar Medical Technologies) 1 and 3 months after the last laser treatment in 3 different "scar" patient groups (time frame: at 1 and 3 months). The study lists 3 primary outcomes in all. 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 5 Dec 2014.