Ablative 10600 nm Fractional Laser Therapy for the Treatment of Scars
Rationale: Scars can be highly disfiguring and may result in functional impairment and psychosocial problems. Recently, fractional laser therapy (FLT) has been introduced as a promising novel treatment modality for scars.
Objectives: The primary objective of this study is to assess the efficacy and safety of 10600 nm FLT for the treatment of different types of scars.
Study design: Prospective observer blinded randomised controlled split-lesion trial.
Study population: Thirty consecutive patients, aged at least 18 years, with hypertrophic or atrophic scars who give written informed consent.
Methods: Two similar test regions of the scar will be randomly allocated to either 3 sessions of FLT (UltraPulse Encore 10600 nm Total FX) with an interval of 4 weeks or no treatment.
Main study parameters/endpoints: Blinded Physicians Global Assessment is the main outcome variable. Secondary variables are Patient's Global Assessment, blinded clinical assessment of the scar on a scale from 0-3 (erythema, pigmentation, texture, hypertrophy, atrophy, pliability), Patient and Observer Scar Scale (POSAS), objective colour measurements by reflectance spectroscopy (LAB) and chromameter (erythema index, melanin index).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects participating in the study will be requested to visit the SNIP (Amsterdam) 3 times for treatment and 2 times for follow-up. The time investment per visit will be 30 minutes for treatment sessions and 20 minutes for follow-up visits. FLT using a 10600 nm laser device is a minimally invasive laser procedure with FDA approval for both the device (Lumenis Encore 10600 nm) and the indication (scar). Local side effects are erythema (always; 1-2 weeks), oozing (often; 1-3 days), swelling (always, 1-4 days), blisters < 0.5cm (occasionally) and blisters > 0.5cm (very rare). No systemic side effects are known for this laser device.
All outcome measures involve non-invasive procedures. The laser treatment (FLT) requires local anesthesia. The amount of topical anesthetic used for infiltration is low (approximately 5% of the maximum dose) which minimizes the risk for local or systemic side effects due to the anesthetic agent.
All together the burden due to the study is moderate, side effects are generally local and mild. Systemic side effects are not reported with this treatment. There is an indirect benefit for the participating subject. In case of improvement of the treated test regions, this therapy can be directly utilized to treat the whole scar.
Considering the relative lack of alternative treatment options in many of these scars, the balance between burden, possible side effects and prospect for improvement is very favorable.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ablative 10600 nm Fractional Laser Therapy for the Treatment of Scars; a Randomized Controlled Trial|
- Improvement of the scar [ Time Frame: 18 months ] [ Designated as safety issue: No ]Improvement of erythema, pigment, and structure of the scar assessed by a blinded dermatologist (blinded physician global assessment) and by objective colour measurements (chromameter)
- Patients satisfaction [ Time Frame: 18 months ] [ Designated as safety issue: No ]Improvement of the scar assessed by the patient(Patient's global assessment)
|Study Start Date:||May 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: laser||
Device: ablative 10600 nm fractional laser therapy
Half of the scar, or one of two comparable scars, will be treated with the ablative 10600 nm fractional laser. There wil be 3 treatments, with 8 weeks apart.
Half of the scar, or one of two comparable scars, will receive no treatment at all.
|No Intervention: no laser|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358838
|The Netherlands Institute for Pigment Disorders|