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

NCT02032641 | Completed Results

• 1 other identifier: 20120936
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Scar

Keywords

Non-ablative laser; Scar revision; direct brow lift

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Appearance

  10 minutes before first treatment and at the final visit

• Hair Loss

  within 1 hour after final treatment

Study Arms (2)

Laser Treatment Side

EXPERIMENTAL

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

Control side

NO INTERVENTION

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.

Interventions

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

Also known as: Laser Genesis, Cutera, 1064 microsecond-pulsed Nd:YAG laser

Laser Treatment Side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing or have undergone direct brow lift

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Bascom Palmer Eye Institute

Plantation, Florida, 33324, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Sara T. Wester
• Organization: Bascom Palmer Eye Institute

SWester2@med.miami.edu

3053266132

Study Officials

• Sara Wester, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: January 10, 2014
• Study Start: June 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)