Hair Removal
Conditions
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.
Interventions
DEVICEHair2Go
Hair2Go treatment once a month for 6 months
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed