search
Back to results

Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction

Primary Purpose

Excess Hair Growth

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GentleTouch
Sponsored by
Syneron Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Excess Hair Growth focused on measuring Helos, Hair Removal, Hair Reduction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Physicians Laser & Dermatology Institute, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

755nm alexandrite laser with bipolar RF

Arm Description

GentleTouch (Helos) combines 755nm alexandrite laser energy with bipolar RF energy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Average hair reduction for each anatomical site

Full Information

First Posted
May 28, 2014
Last Updated
May 23, 2016
Sponsor
Syneron Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT02465788
Brief Title
Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction
Official Title
LASER HAIR REDUCTION BY COMBINED BIPOLAR RF AND 755 nm LASER ENERGIES
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syneron Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excess Hair Growth
Keywords
Helos, Hair Removal, Hair Reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
755nm alexandrite laser with bipolar RF
Arm Type
Experimental
Arm Description
GentleTouch (Helos) combines 755nm alexandrite laser energy with bipolar RF energy.
Intervention Type
Device
Intervention Name(s)
GentleTouch
Other Intervention Name(s)
755nm alexandrite laser energy with bipolar RF, Helos
Intervention Description
Four distinct areas on each selected anatomical area will be treated with different treatment parameters.
Primary Outcome Measure Information:
Title
Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment
Description
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.
Time Frame
Baseline, 3 months after last treatment
Secondary Outcome Measure Information:
Title
Average hair reduction for each anatomical site
Time Frame
6-12 months after last treatment
Other Pre-specified Outcome Measures:
Title
Side Effects and Adverse Events
Description
Safety will be evaluated based on the incidence and severity of adverse events caused by the laser treatments
Time Frame
one year
Title
Histologic analysis of H&E stained tissue sections from biopsies
Description
Post-treatment biopsies may be taken at any time between the first treatment visit and the second treatment visit, prior to treatment.
Time Frame
day 1
Title
Numerical Response Scale for Rating Pain (NRS)
Description
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.
Time Frame
every 4-6 weeks up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomit Mann
Organizational Affiliation
Syneron Medical Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Physicians Laser & Dermatology Institute, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction

We'll reach out to this number within 24 hrs