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

Primary Purpose

Scar

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser treatment
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring Non-ablative laser, Scar revision, direct brow lift

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bascom Palmer Eye Institute
  • Bascom Palmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser Treatment Side

Control side

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Relative Improvement
Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs

Secondary Outcome Measures

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
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

Full Information

First Posted
June 24, 2013
Last Updated
January 24, 2017
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02032641
Brief Title
Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars
Official Title
Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
Non-ablative laser, Scar revision, direct brow lift

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Treatment Side
Arm Type
Experimental
Arm Description
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.
Arm Title
Control side
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laser treatment
Other Intervention Name(s)
Laser Genesis, Cutera, 1064 microsecond-pulsed Nd:YAG laser
Intervention Description
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
Primary Outcome Measure Information:
Title
Relative Improvement
Description
Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs
Time Frame
1 month after final treatment
Secondary Outcome Measure Information:
Title
Overall Appearance
Description
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
Time Frame
10 minutes before first treatment and at the final visit
Title
Hair Loss
Description
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
Time Frame
within 1 hour after final treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Wester, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Submitted for publication but no individual participant data released

Learn more about this trial

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

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