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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hair Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Wester, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States | ||
| Bascom Palmer Eye Institute |
Submitted for publication but no individual participant data released
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics refer to brows, not participants, as each participant underwent treatment of one brow and the other brow was a control.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Improvement | Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs | 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). | Posted | Mean | Standard Deviation | percentage of times treated scar chosen | 1 month after final treatment | BROW | BROW |
|
2 years, 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser Right, Non-laser Left | Group which had the right post-operative scar assigned to receive laser treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara T. Wester | Bascom Palmer Eye Institute | 3053266132 | SWester2@med.miami.edu |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
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 |
| Plantation |
| Florida |
| 33324 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Control Scar | 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. |
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | units on a scale | 10 minutes before first treatment and at the final visit | BROW | BROW |
|
|
|
|
| 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 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 | Posted | Mean | Standard Deviation | units on a scale | within 1 hour after final treatment | BROW | BROW |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Laser Left, Non-laser RIght | Group which had the right post-operative scar assigned to receive laser treatment | 0 | 4 | 0 | 4 |
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The threshold for significance is p<0.05
| Superiority or Other |