Scar
Conditions
Keywords
Non-ablative laser, Scar revision, direct brow lift
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.
Interventions
DEVICELaser 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
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Improvement | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Appearance | 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 |
| Hair Loss | 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 |
Countries
United States
Participant flow
Recruitment details
All patients who had undergone direct brow lift within the last three years were contacted by telephone, and an approved script was used for recruitment.
Pre-assignment details
Exclusion criteria included unilateral procedures, age less than 18 years, pregnancy, history of photodermatoses or adverse outcomes associated with laser, history of isotretinoin use within the prior six months, and active use of other scar treatment in the brow area.
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatment and Control Group Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which 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. The laser 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.
Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Laser Treatment and Control Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Relative Improvement
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
Population: 3 graders masked to treatments were asked to judge side-by-side photographs of first and final visits for which scar improved more. Each pair of before-and-after photos was graded twice by each examiner. Results are percentage of times treated scar was chosen by examiners as most improved (an analysis of 6 results per pair of photos).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser Treatment Side | Relative Improvement | 50.0 percentage of times treated scar chosen | Standard Deviation 12.5 |
| Control Scar | Relative Improvement | 50.0 percentage of times treated scar chosen | Standard Deviation 12.5 |
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
Time frame: within 1 hour after final treatment
Population: Within 1 hour after treatment, subjects were given a mirror and asked to rate perceived hair loss for each side on a 1-10 scale, with 1 representing none and 10 representing very significant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser Treatment Side | Hair Loss | 1 units on a scale | Standard Deviation 0 |
| Control Scar | Hair Loss | 1 units on a scale | Standard Deviation 0 |
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
Time frame: 10 minutes before first treatment and at the final visit
Population: Patients were asked to grade overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent. Grading was done 10 minutes prior to each laser treatment and 4 weeks after final treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laser Treatment Side | Overall Appearance | Before first treatment | 3.75 units on a scale | Standard Deviation 2.12 |
| Laser Treatment Side | Overall Appearance | Final visit | 6.25 units on a scale | Standard Deviation 1.98 |
| Control Scar | Overall Appearance | Before first treatment | 4.37 units on a scale | Standard Deviation 1.5 |
| Control Scar | Overall Appearance | Final visit | 4.50 units on a scale | Standard Deviation 2.62 |
p-value: <0.05t-test, 1 sided
p-value: >0.1t-test, 1 sided