Long Term Efficiency of the Hair2Go Device

Hair Removal Clinical Trial

— OHR-8-FU-1Y  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529931
• Other study ID #: OHR-8-FU-1Y
• Secondary ID: DC83411
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2019
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hair Removal

Intervention

Device:
• Hair2Go
Hair2Go treatment once a month for 6 months

Locations

Country	Name	City	State
United States	Dr Jerome Garden	Chicago	Illinois
United States	Zel Skin & Laser Specialists	Edina	Minnesota
United States	South Dermatology Institute	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)