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Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction

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ClinicalTrials.gov Identifier: NCT02465788
Recruitment Status : Unknown
Verified May 2016 by Syneron Medical.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Excess Hair Growth Device: GentleTouch Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LASER HAIR REDUCTION BY COMBINED BIPOLAR RF AND 755 nm LASER ENERGIES
Study Start Date : May 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: 755nm alexandrite laser with bipolar RF
GentleTouch (Helos) combines 755nm alexandrite laser energy with bipolar RF energy.
Device: GentleTouch
Four distinct areas on each selected anatomical area will be treated with different treatment parameters.
Other Names:
  • 755nm alexandrite laser energy with bipolar RF
  • Helos




Primary Outcome Measures :
  1. Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Average hair reduction for each anatomical site [ Time Frame: 6-12 months after last treatment ]

Other Outcome Measures:
  1. Side Effects and Adverse Events [ Time Frame: one year ]
    Safety will be evaluated based on the incidence and severity of adverse events caused by the laser treatments

  2. Histologic analysis of H&E stained tissue sections from biopsies [ Time Frame: day 1 ]
    Post-treatment biopsies may be taken at any time between the first treatment visit and the second treatment visit, prior to treatment.

  3. Numerical Response Scale for Rating Pain (NRS) [ Time Frame: every 4-6 weeks up to 24 weeks ]
    To evaluate subject's assessment of comfort associated with treatments. Treatment related pain will be assessed immediately after treatment, the subject will be asked to define how much pain they felt from treatment by choosing a number from 0 to 10.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465788


Locations
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United States, Illinois
Physicians Laser & Dermatology Institute, LLC
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Syneron Medical
Investigators
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Study Director: Shlomit Mann Syneron Medical Ltd.

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Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT02465788     History of Changes
Other Study ID Numbers: IH141302
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Syneron Medical:
Helos
Hair Removal
Hair Reduction