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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
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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)
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