Trial Outcomes & Findings for Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars (NCT NCT02032641)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

1 month after final treatment

Results posted on

2017-01-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser Treatment and Control Group n=9 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	Laser Treatment Side n=8 BROW 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.	Control Scar n=8 BROW 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.
Relative Improvement	50.0 percentage of times treated scar chosen Standard Deviation 12.5	50.0 percentage of times treated scar chosen Standard Deviation 12.5

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Laser Treatment Side n=8 BROW 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.	Control Scar n=8 BROW 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.
Overall Appearance Before first treatment	3.75 units on a scale Standard Deviation 2.12	4.37 units on a scale Standard Deviation 1.50
Overall Appearance Final visit	6.25 units on a scale Standard Deviation 1.98	4.50 units on a scale Standard Deviation 2.62

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Laser Treatment Side n=8 BROW 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.	Control Scar n=8 BROW 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.
Hair Loss	1 units on a scale Standard Deviation 0	1 units on a scale Standard Deviation 0

Adverse Events

Laser Right, Non-laser Left

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser Left, Non-laser RIght

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sara T. Wester

Bascom Palmer Eye Institute

Phone: 3053266132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place