Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction

Syneron Medical

Status

Unknown

Conditions

Excess Hair Growth

Treatments

Device: GentleTouch

Study type

Interventional

Funder types

Industry

Identifiers

NCT02465788

IH141302

Details and patient eligibility

About

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.

Full description

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.

Enrollment

29 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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