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Long Term Efficiency of the Hair2Go Device (OHR-8-FU-1Y)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01529931
First received: February 6, 2012
Last updated: October 13, 2016
Last verified: October 2016

February 6, 2012
October 13, 2016
January 2012
October 2012   (final data collection date for primary outcome measure)
Hair clearance at final follow up [ Time Frame: 1 year after last basic treatment (termination) ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT01529931 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long Term Efficiency of the Hair2Go Device
Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Hair Removal
Device: Hair2Go
Hair2Go treatment once a month for 6 months
Other Name: Mē my elōs
Experimental: Maintenance
This arm receives Hair2Go treatments once a month for 6 months
Intervention: Device: Hair2Go
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
November 2012
October 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01529931
OHR-8-FU-1Y, DC83411
No
No
Only 5 subjects enrolled into this protocol. Data was combined with OHR2-1Y protocol and reported under that study.
Syneron Medical
Syneron Medical
Not Provided
Principal Investigator: Jerome M Garden, MD Northwestern Memorial Hospital
Principal Investigator: Vince Afsahi, MD South Coast Dermatology Institute
Principal Investigator: Brian D Zelickson, MD Abbot Northwestern Hospital Center for Cosmetic Care
Investigator: Lilach Gavish, PhD Hebrew University of Jerusalem
Syneron Medical
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP