Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of the 1064nm Neodymium yttrium aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar after direct brow lift.

Detailed Description
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Patients who undergo a direct brow lift may participate in this study. Participants will receive laser treatment on one of the two surgical wounds (side of treatment will be chosen randomly by an independent source). Treatment parameters will be 500 spots and 10-14 megajoules (mJ) depending on skin type. The opposite side brow scar will not be treated until 1 month after the study is completed (if the patient elects to treat the contralateral brow after study completion this will be done at no charge to the patient). This treatment will be given at 2-4 week intervals for 6 treatments. Photographs will be taken at each visit, and they will be assessed based on different parameters by an examiner, as well as judged by the patient based on overall appearance.

Official Title
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Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars

Conditions
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Scar

Intervention / Treatment
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* Device: Laser treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing or have undergone direct brow lift Exclusion Criteria: under 18 years old history of photodermatoses receiving systemic isotretinoin within the preceding 6 months undergoing other scar treatment in the brow area pregnant patients history of adverse outcomes related to non-ablative laser

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Laser Treatment Side<br>Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage. | Device: Laser treatment<br>* Non-ablative, non-fractional, microsecond-pulsed Nd:YAG laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size<br>* Other names: 1064 microsecond-pulsed Nd:YAG laser;|
| No Intervention: Control side<br>Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Improvement | Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs | 1 month after final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Appearance | Subjects were asked to rate overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent, as rated by participant | 10 minutes before first treatment and at the final visit | 
| Hair Loss | After each laser session, subjects were asked to rate perceived amount of hair loss from both the treated and control scars on a 1-10 scale, with 1 being none at all and 10 being extremely significant | within 1 hour after final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-ablative laser, Scar revision, direct brow lift