Long Term Efficiency of the Hair2Go Device

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hair Removal

Intervention / Treatment
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* Device: Hair2Go


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed the basic treatments of OHR-2, OHR-3, or OHR-5-Face studies. Healthy males and females, between 18 and 65 years of age. Willing to sign informed consent. Willing to follow the protocol schedule. Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications Willingness to avoid shaving 1 week prior to the visits. Exclusion Criteria: Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil) Subject had electrolysis treatment within the last 6 months over the treatment area. 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance<br>This arm receives Hair2Go treatments once a month for 6 months | Device: Hair2Go<br>* Hair2Go treatment once a month for 6 months<br>* Other names: Mē my elōs;|

What is the study measuring?
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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) |