Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction

Launched by SYNERON MEDICAL · Jun 4, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is not pregnant and does not plan to become pregnant during their 16 month study period
• • 2. 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
• • 3. 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
• • 4. Subject is willing to participate in the study
• • 5. 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
• • 6. Subject has the ability to adhere to post treatment care requirements.
• • 7. Subject can commit to follow-up schedule
• • 8. 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
• • 9. Subject can read and comprehend English
• • 10. Subject has completed the Informed Consent Form (ICF)
• Exclusion Criteria:
• • 1. Subject has only white, red, blond or grey hairs in the treatment areas
• • 2. Subject has injury, scarring or infection in the treatment areas
• • 3. Subject has a tattoo in the treatment areas
• • 4. 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
• • 5. Subject is not willing to have long term hair loss in the treated areas
• • 6. Subject is not willing to discontinue shaving treatment areas at least one week prior to treatment and follow-up visits
• • 7. Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc
• • 8. Subject is photosensitive due to having a condition such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
• • 9. Subject has used Accutane or other oral retinoic acid therapy in the past 6 months
• • 10. Subject has a known anticoagulation or thromboembolic condition
• • 11. Subject is taking anticoagulation medication
• • 12. Subject has a known history of hypertrophic or keloid scars following skin injury
• • 13. Subject has known collagen vascular disease such as scleroderma, lupus, etc
• • 14. Subject is immunocompromised (including HIV infection or AIDS) or currently using immunosuppressive medications
• • 15. Subject had rotating type tweezer epilator treatment, or waxing within the last 3 months
• • 16. Subject had electrolysis treatment over the treatment areas
• • 17. Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment areas
• • 18. Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated
• • 19. Subject has participated in a study of another device or drug within 1 month prior to enrollment or during this study
• • 20. Subject has allergy to lidocaine