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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypopigmented scars treated with laser | Active Comparator | patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece |
|
| hypopigmented scars treated without laser | Placebo Comparator | patients with hypopigmented scars treated without laser |
|
| hypertrophic scars treated with laser | Active Comparator |
| |
| hypertrophic scars not treated with laser | Placebo Comparator |
| |
| scars due to grafts and reconstructions treated with laser | Active Comparator | scars due to grafts and reconstructions in the head and neck region |
|
| grafts and reconstructions scars not treated with laser | Placebo Comparator | scars due to grafts and reconstructions in the head and neck region |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laser treatment | Procedure | Starlux 300 Lux 1540nm Fractional laser hand piece |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site | at 1 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of skin redness and pigmentation | 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 | at 1 and 3 months after treatment |
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The patients needs to have a scar fulfilling the inclusion and exclusion criteria of one of the 3 patient groups:
Patient group 1: patients with hypopigmented scars :
Inclusion criteria:
Exclusion criteria:
Patientgroup 2: patients with hypertrophic scars :
Inclusion criteria:
Exclusion criteria:
Patient group 3: Patients with scars due to grafts and reconstructions in the head and neck region.
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelien Verhaeghe, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerisity Hospital Ghent | Ghent | Belgium |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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|
| treatment without laser | Procedure | Starlux 300 Lux 1540nm Fractional laser hand piece |
|
| laser treatment | Procedure | Starlux 300 Lux 1540nm Fractional laser hand piece |
|
| 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 |
| Photografic documentation of scar improvement | 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 |
| D055618 | Radiation Equipment and Supplies |