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Completed

NCT Number: NCT02032641

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bascom Palmer Eye Institute, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser treatment

Device

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

Other names: Laser Genesis, Cutera, 1064 microsecond-pulsed Nd:YAG laser

Primary outcomes

  1. Relative Improvement

    Time frame: 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 outcomes

  1. Overall Appearance

    Time frame: 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

  2. Hair Loss

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 10, 2014
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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