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

NCT ID: NCT02032641

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Laser treatment

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sara T. Wester

Ophthalmologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Wester, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Bascom Palmer Eye Institute

Miami, Florida, United States

Bascom Palmer Eye Institute

Plantation, Florida, United States

Countries

United States

Other Identifiers

20120936

Identifier Type: -

Identifier Source: org_study_id