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Completed

NCT Number: NCT01529931

Long Term Efficiency of the Hair2Go Device

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Dermatology Institute, Tustin, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hair2Go

Device

Hair2Go treatment once a month for 6 months

Other names: Mē my elōs

Primary outcomes

  1. Hair clearance at final follow up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Syneron Medical

Industry

Registry information

Official study title

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

Acronym: OHR-8-FU-1Y

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2012
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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