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

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ClinicalTrials.gov Identifier: NCT02032641
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Sara T. Wester, 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.

Condition or disease Intervention/treatment Phase
Scar Device: Laser treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars
Study Start Date : June 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Laser Treatment Side
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
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

No Intervention: Control side
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032641


Locations
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United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Bascom Palmer Eye Institute
Plantation, Florida, United States, 33324
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Sara Wester, MD University of Miami

Additional Information:
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Responsible Party: Sara T. Wester, Ophthalmologist, University of Miami
ClinicalTrials.gov Identifier: NCT02032641     History of Changes
Other Study ID Numbers: 20120936
First Posted: January 10, 2014    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Submitted for publication but no individual participant data released
Keywords provided by Sara T. Wester, University of Miami:
Non-ablative laser
Scar revision
direct brow lift
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes