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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032641
• Other study ID #: 20120936
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: January 24, 2017
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: January 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scar

Intervention

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

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	Bascom Palmer Eye Institute	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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