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

Not Applicable

Completed

• Conditions: Scar
• Interventions: Device: Laser treatment

• Registration Number: NCT02032641
• Lead Sponsor: University of Miami

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-04-05
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-24
• Last Update Submitted: 2017-01-24
• Results First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Treatment Side	Laser treatment	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.

Primary Outcome Measures

Name	Time	Method
Relative Improvement	1 month after final treatment	Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs

Secondary Outcome Measures

Name	Time	Method
Overall Appearance	10 minutes before first treatment and at the final visit	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
Hair Loss	within 1 hour after final treatment	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

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Plantation, Florida, United States