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

Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal

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.

Study Overview

• Status: Completed
• Conditions: Hair Removal
• Intervention / Treatment: Device: Hair2Go

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • South Dermatology Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Dr Jerome Garden
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin & Laser Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Mē my elōs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair clearance at final follow up	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.	1 year after last basic treatment (termination)

Collaborators and Investigators

• Sponsor: Syneron Medical
• Investigators: Lilach Gavish, PhD, Hebrew University of Jerusalem

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 9, 2012

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OHR-8-FU-1Y; DC83411 (Other Identifier: Syneron Beauty)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Only 5 subjects enrolled into this protocol. Data was combined with OHR2-1Y protocol and reported under that study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No