1540nm Non Ablative Fractional Laser Treatment of Scars
NCT ID: NCT01056211
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2010-01-31
2013-08-31
Brief Summary
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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 :
1. Patients with hypopigmented scars
2. Patients with hypertrophic scars
3. 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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hypopigmented scars treated with laser
patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece
laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
hypopigmented scars treated without laser
patients with hypopigmented scars treated without laser
treatment without laser
Starlux 300 Lux 1540nm Fractional laser hand piece
hypertrophic scars treated with laser
laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
hypertrophic scars not treated with laser
treatment without laser
Starlux 300 Lux 1540nm Fractional laser hand piece
scars due to grafts and reconstructions treated with laser
scars due to grafts and reconstructions in the head and neck region
laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
grafts and reconstructions scars not treated with laser
scars due to grafts and reconstructions in the head and neck region
treatment without laser
Starlux 300 Lux 1540nm Fractional laser hand piece
Interventions
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laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
treatment without laser
Starlux 300 Lux 1540nm Fractional laser hand piece
laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Evelien Verhaeghe, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Univerisity Hospital Ghent
Ghent, , Belgium
Countries
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Other Identifiers
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2009/626
Identifier Type: -
Identifier Source: org_study_id