Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction

Study Overview
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Brief Summary
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The objective of this post marketing study is to further explore a variety of treatment parameters in order to optimize the optical (laser) and electrical (RF) treatments over the various skin types, when using a combination 755 nm alexandrite laser together with a bipolar RF energy system, for the purpose of hair reduction.

Detailed Description
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The study device (Helos) combines 755nm alexandrite laser energy with bipolar RF energy. The laser can deliver 0.25 to 100 ms laser pulses at a maximum of 20 J/cm2. Bipolar RF energy will be delivered across the laser beam via two appropriately sized electrodes and spacing between the electrodes. Bipolar RF energy may be delivered at a maximum of 35 J operating at 1 MHz. Typical RF pulses will be of duration of between 100 and 300ms. Epidermal cooling is accomplished via contact with a cooled window.

Official Title
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LASER HAIR REDUCTION BY COMBINED BIPOLAR RF AND 755 nm LASER ENERGIES

Conditions
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Excess Hair Growth

Intervention / Treatment
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* Device: GentleTouch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is not pregnant and does not plan to become pregnant during their 16 month study period Subject has a minimum terminal hair density of 15 black or brown hairs in all 3cm x 3cm hair count evaluation areas. To distinguish terminal hair from vellus hair: terminal hairs are thicker, longer, and darker compared to vellus hairs which are short, fine and lightly color Subject is willing to have 5cm x 5cm square patches of reduced hair on all treatment areas for some time during and after the study period, perhaps even permanently Subject is willing to participate in the study Subject is willing to avoid sun exposure and tanning of the treatment areas for a time spanning two weeks before the first treatment to two weeks after the last treatments Subject has the ability to adhere to post treatment care requirements. Subject can commit to follow-up schedule Subject is willing to have photographs taken of the treated area which will be used de-identified in evaluations and may be used de-identified in presentations and/or publications Subject can read and comprehend English Subject has completed the Informed Consent Form (ICF) Exclusion Criteria: Subject has only white, red, blond or grey hairs in the treatment areas Subject has injury, scarring or infection in the treatment areas Subject has a tattoo in the treatment areas Subject is pregnant or is lactating or plans to become pregnant during their 16 month study period. Pregnancy will be assessed by question at screening Subject is not willing to have long term hair loss in the treated areas Subject is not willing to discontinue shaving treatment areas at least one week prior to treatment and follow-up visits Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc Subject is photosensitive due to having a condition such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc Subject has used Accutane or other oral retinoic acid therapy in the past 6 months Subject has a known anticoagulation or thromboembolic condition Subject is taking anticoagulation medication Subject has a known history of hypertrophic or keloid scars following skin injury Subject has known collagen vascular disease such as scleroderma, lupus, etc Subject is immunocompromised (including HIV infection or AIDS) or currently using immunosuppressive medications Subject had rotating type tweezer epilator treatment, or waxing within the last 3 months Subject had electrolysis treatment over the treatment areas Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment areas Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated Subject has participated in a study of another device or drug within 1 month prior to enrollment or during this study Subject has allergy to lidocaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: 755nm alexandrite laser with bipolar RF<br>GentleTouch (Helos) combines 755nm alexandrite laser energy with bipolar RF energy. | Device: GentleTouch<br>* Four distinct areas on each selected anatomical area will be treated with different treatment parameters.<br>* Other names: Helos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment | The primary efficacy endpoint is to measure the average percentage of hair reduction at 3 months post last treatment computed over all subjects and all treatment sites. Hair reduction will be evaluated by counting the number of terminal hairs present in the 3 cm by 3 cm defined region by at least two independent blinded trained reviewers of photos taken at baseline and at the follow-up visits. | Baseline, 3 months after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average hair reduction for each anatomical site |  | 6-12 months after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hair Removal, Hair Reduction, Helos