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Long Term Efficiency of the Hair2Go Device (OHR-8-FU-1Y)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01529931
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : January 18, 2019
Information provided by (Responsible Party):
Syneron Medical

Brief Summary:
The current study is a follow up study designed to gather information about the effect of the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic Hair2Go treatment. This study includes taking photos and documenting endpoints but does not include treatments.

Condition or disease Intervention/treatment Phase
Hair Removal Device: Hair2Go Not Applicable

Detailed Description:

The Hair2Go device is intended for short-term and long-term removal of unwanted hair adjunctive to shaving. The device uses a technology called Elōs, which is a combination of electrical field at radio frequencies (RF) and intense optical energy, that are simultaneously applied to the tissue and were found to have synergistic effects. Thus, lower levels of both energies are used to facilitate the treatment for individuals of all skin types and hair colors.

This study is a multicenter study. Subjects that completed the basic treatments of previous Hair2Go studies (OHR-2, OHR-3, or OHR-5-Face) will be offered the option to enroll in this study that will not include treatments. The individual data collected in the OHR-2 (and its extensions, i.e. OHR2-P and OHR2-1Y), OHR-3, and OHR-5-Face studies will be used for the analysis together with data gathered in this study. Photographs of the previously treated areas will be taken 3, 6, 9, and 12 months after the last basic treatment if they were not already taken as part of the OHR-2, one of its extensions (i.e. OHR2-P and OHR2-1Y), or OHR-5-Face.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal
Study Start Date : January 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: Maintenance
This arm receives Hair2Go treatments once a month for 6 months
Device: Hair2Go
Hair2Go treatment once a month for 6 months
Other Name: Mē my elōs

Primary Outcome Measures :
  1. Hair clearance at final follow up [ Time Frame: 1 year after last basic treatment (termination) ]
    Hair clearance will be calculated at the final follow-up treatment from the hair counts conducted by independent blinded reviewer(s) based on photographs of treatment sites.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Completed the basic treatments of OHR-2, OHR-3, or OHR-5-Face studies.
  2. Healthy males and females, between 18 and 65 years of age.
  3. Willing to sign informed consent.
  4. Willing to follow the protocol schedule.
  5. Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
  6. Willingness to avoid shaving 1 week prior to the visits.

Exclusion Criteria:

  1. Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil)
  2. Subject had electrolysis treatment within the last 6 months over the treatment area.
  3. Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site (with the exception of treatments within the OHR-2, OHR-2P, OHR2-1Y, OHR-3, or OHR-5-Face protocol).

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 identifier (NCT number): NCT01529931

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United States, California
South Dermatology Institute
Tustin, California, United States, 92780
United States, Illinois
Dr Jerome Garden
Chicago, Illinois, United States, 60611
United States, Minnesota
Zel Skin & Laser Specialists
Edina, Minnesota, United States, 55424
Sponsors and Collaborators
Syneron Medical
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Principal Investigator: Jerome M Garden, MD Northwestern Memorial Hospital
Principal Investigator: Vince Afsahi, MD South Coast Dermatology Institute
Principal Investigator: Brian D Zelickson, MD Abbot Northwestern Hospital Center for Cosmetic Care
OverallOfficial: Lilach Gavish, PhD Hebrew University of Jerusalem

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Responsible Party: Syneron Medical Identifier: NCT01529931     History of Changes
Other Study ID Numbers: OHR-8-FU-1Y
DC83411 ( Other Identifier: Syneron Beauty )
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only 5 subjects enrolled into this protocol. Data was combined with OHR2-1Y protocol and reported under that study.

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Studies a U.S. FDA-regulated Drug Product: No