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The objective of this clinical study is to verify hair count reduction, associated comfort/discomfort and treatment time using the LightSheer Duet System with the High Speed (HS) handpieces for temporary hair removal and permanent hair reduction. It is anticipated that the larger treatment size of the HS handpiece will result in faster treatment of larger areas; and that the lower energy levels will result in greater comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS treatment | Experimental | Treatment with HS handpiece |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LightSheer Duet | Device | LightSheer Duet HS handpiece |
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| Measure | Description | Time Frame |
|---|---|---|
| Hair Count | The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline. | 6 month following last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Time | The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants. | Each treatment |
| Level of Comfort Associated With Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Medical Group Inc | Sacramento | California | 95816 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HS Treatment | Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The power calculation proposed a sample of 35 participants to be sufficient to obtain qualitative assessment of hair removal, as well as the qualitative assessment of treatment time and pain experienced during treatment with the LightSheer Duet HS handpiece.
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| ID | Title | Description |
|---|---|---|
| BG000 | HS Treatment | Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Hair Count | The hair at the treatment area is counted at Baseline and 6 months following the last treatment. Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline. | Posted | Mean | Standard Deviation | percentage of hair clearance | 6 month following last treatment |
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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 | HS Treatment | Treatment with the LightSheer Duet laser HS handpiece: Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels. All patients were treated in the Axilla area. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injured ankle | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Kilmer, MD | Laser & Skin Surgery Medical Group Inc. | 916-456-0400 | Study@skinlasers.com |
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| Each treatment |
| Hair Count | The hair at the treatment area is counted at Baseline and 15 months following the last treatment. Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline. | 15 month following last treatment |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Treatment Time | The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants. | Posted | Mean | Standard Deviation | minutes | Each treatment |
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| Secondary | Level of Comfort Associated With Treatment | Not Posted | Each treatment |
| Secondary | Hair Count | The hair at the treatment area is counted at Baseline and 15 months following the last treatment. Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline. | The number of participants who completed 15 months follow up was 23 out of 35. | Posted | Mean | Standard Deviation | percentage of hair clearance | 15 month following last treatment |
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| 1 |
| 35 |
| 0 |
| 35 |
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