1540nm Non Ablative Fractional Laser Treatment of Scars

Study Overview
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Brief Summary
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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 : 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.

Official Title
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1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.

Conditions
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Scars

Intervention / Treatment
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* Procedure: laser treatment
* Procedure: treatment without laser
* Procedure: laser treatment


Participation Criteria
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Eligibility Criteria
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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: 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 Exclusion criteria: Pregnancy and lactation Oral retinoid drugs within the past 6 months Patientgroup 2: patients with hypertrophic scars : Inclusion criteria: 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 Exclusion criteria: 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. Inclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hypopigmented scars treated with laser<br>patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece | Procedure: laser treatment<br>* Starlux 300 Lux 1540nm Fractional laser hand piece<br>|
| Placebo Comparator: hypopigmented scars treated without laser<br>patients with hypopigmented scars treated without laser | Procedure: treatment without laser<br>* Starlux 300 Lux 1540nm Fractional laser hand piece<br>|
| Active Comparator: hypertrophic scars treated with laser<br> | Procedure: laser treatment<br>* Starlux 300 Lux 1540nm Fractional laser hand piece<br>|
| Placebo Comparator: hypertrophic scars not treated with laser<br> | Procedure: treatment without laser<br>* Starlux 300 Lux 1540nm Fractional laser hand piece<br>|
| Active Comparator: scars due to grafts and reconstructions treated with laser<br>scars due to grafts and reconstructions in the head and neck region | Procedure: laser treatment<br>* Starlux 300 Lux 1540nm Fractional laser hand piece<br>Procedure: laser treatment<br>* Starlux 300 Lux 1540nm Fractional laser hand piece<br>|
| Placebo Comparator: grafts and reconstructions scars not treated with laser<br>scars due to grafts and reconstructions in the head and neck region | Procedure: treatment without laser<br>* Starlux 300 Lux 1540nm Fractional laser hand piece<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |