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

This study has been completed.
Information provided by (Responsible Party):
Syneron Medical Identifier:
First received: February 6, 2012
Last updated: October 13, 2016
Last verified: October 2016
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 Intervention
Hair Removal
Device: Hair2Go

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal

Further study details as provided by Syneron Medical:

Primary Outcome Measures:
  • Hair clearance at final follow up [ Time Frame: 1 year after last basic treatment (termination) ] [ Designated as safety issue: No ]
    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.

Enrollment: 5
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01529931

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
St. Edina, Minnesota, United States, 55424
Sponsors and Collaborators
Syneron Medical
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
  More Information

Responsible Party: Syneron Medical Identifier: NCT01529931     History of Changes
Other Study ID Numbers: OHR-8-FU-1Y  DC83411 
Study First Received: February 6, 2012
Last Updated: October 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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. processed this record on October 21, 2016