Long Term Efficiency of the Hair2Go Device

Not Applicable

Completed

• Conditions: Hair Removal
• Interventions: Device: Hair2Go

• Registration Number: NCT01529931
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-09
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maintenance	Hair2Go	This arm receives Hair2Go treatments once a month for 6 months

Primary Outcome Measures

Name	Time	Method
Hair clearance at final follow up	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.

Trial Locations

Locations (3)

South Dermatology Institute; 🇺🇸 Tustin, California, United States

Zel Skin & Laser Specialists; 🇺🇸 Edina, Minnesota, United States

Dr Jerome Garden; 🇺🇸 Chicago, Illinois, United States