1540nm Non Ablative Fractional Laser Treatment of Scars
- Conditions
- Scars
- Interventions
- Procedure: laser treatmentProcedure: treatment without laser
- Registration Number
- NCT01056211
- Lead Sponsor
- University Hospital, Ghent
- Brief 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 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hypertrophic scars treated with laser laser treatment - hypopigmented scars treated with laser laser treatment patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece scars due to grafts and reconstructions treated with laser laser treatment scars due to grafts and reconstructions in the head and neck region grafts and reconstructions scars not treated with laser treatment without laser scars due to grafts and reconstructions in the head and neck region hypopigmented scars treated without laser treatment without laser patients with hypopigmented scars treated without laser hypertrophic scars not treated with laser treatment without laser -
- Primary Outcome Measures
Name Time Method Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site at 1 and 3 months 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 at 1 and 3 months Evaluation of the treatment related pain at 1 and 3 months
- Secondary Outcome Measures
Name Time Method Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment at 1 and 3 months after treatment Physician assessment for the treated and control region (PhGA) at 1 and 3 months after treatment patient assessment for the treated and control region at 1 and 3 months after treatment Evaluation of skin redness and pigmentation at 1 and 3 months after treatment Evaluation of histological difference in treated an non treated parts of the scar at 3 months after treatment Photografic documentation of scar improvement at 1 and 3 months after treatment
Trial Locations
- Locations (1)
Univerisity Hospital Ghent
🇧🇪Ghent, Belgium