Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Study Overview
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Brief Summary
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The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction. Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site. Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.

Official Title
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Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Conditions
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Hair Removal

Intervention / Treatment
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* Device: LightSheer Duet HS handpiece


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read, understand and provide written Informed Consent; Healthy adult, male or female, 18 years of age or older with skin type I-IV; Having a suitable treatment area for hair removal; Able and willing to comply with the treatment/follow-up schedule and requirements; Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study. Exclusion Criteria: Pregnant, expectation of pregnancy, postpartum or nursing (<6 months); Hormonal disorders that may affect hair growth; Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications; Livedo reticularis; Uncontrolled systemic diseases such as diabetes; Active infections in the treated area; Dysplastic nevi; Significant concurrent skin conditions or any inflammatory skin conditions; Active cold sores, open lacerations or abrasions; Chronic or cutaneous viral, fungal, or bacterial diseases; Current cancer; History of skin cancer or pre-cancerous lesions at the treatment areas; Use of Accutane™ (Isotretinoin) within the past six month; Keloid formation in the treatment area; Tattoos in the treatment area; Bleeding coagulopathies or use of anticoagulants; Auto-immune disorders; Erythema ab igne, when identified treatments should be discontinued; Photosensitivity disorder that can be exacerbated by laser or intense light; Herpes simplex in the treatment area; Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light; Poor wound healing; Sunburns; Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the evaluation; Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hair removal<br>hair removal treatment using 805nm LightSheer Duet HS handpiece | Device: LightSheer Duet HS handpiece<br>* The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events | To evaluate the safety of hair removal using the LightSheer Duet HS 805 nm handpiece | 1 year | 
| Hair count | To verify hair removal and permanent hair reduction using the LightSheer Duet HS 805 nm handpiece | 6 monts follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's comfort using VAS | To evaluate subject's assessment of comfort associated with treatments | Baseline, 4, 8, 12, 16 weeks; | 
| Asses subject's perception of improvement and satisfaction | To evaluate subject's satisfaction with hair removal treatments and assessment of improvement using subject's questionnaire | 8, 16 weeks following baseline; 3 and 6 monts follow up |