The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01348776
First received: May 2, 2011
Last updated: April 2, 2013
Last verified: April 2013
Results First Received: December 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hair Removal
Intervention: Device: Hair2Go (Mē)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment was conducted in a medical clinic. The recruitment continued from April to October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 subjects were found not eligible and 1 withdrew the informed consent before beginning treatments.

Reporting Groups
  Description
Hair2Go (Me) Subjects treated with the Hair2Go (Me) Device

Participant Flow:   Overall Study
    Hair2Go (Me)  
STARTED     87 [1]
COMPLETED     84  
NOT COMPLETED     3  
Lost to Follow-up                 3  
[1] 3 subjects were lost to follow-up: 2 after the 1-month follow-up, 1 after performing 4 treatments



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Hair2Go (Me) Subjects treated with the Hair2Go (Me) Device

Baseline Measures
    Hair2Go (Me)  
Number of Participants  
[units: participants]
  87  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     87  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.4  ± 9  
Gender  
[units: participants]
 
Female     79  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     87  



  Outcome Measures
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1.  Primary:   Hair Clearance 1 Month After Last Treatment   [ Time Frame: 3 months (1 month after 7 weekly treatments) ]

2.  Secondary:   Hair Clearance at 3-month (Final) Follow up   [ Time Frame: 5 months (3 months after 7 weekly treatments) ]

3.  Secondary:   Occurrence of Anticipated Effects on Skin   [ Time Frame: Up to 19 weeks ]

4.  Secondary:   Tolerability Level of the Procedure Following Treatments   [ Time Frame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3) ]

5.  Secondary:   Subject Satisfaction   [ Time Frame: 5 months (final follow up) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Doran Rozen, Director of Clinical Affairs
Organization: Syneron Beauty
phone: +972-54-7800260
e-mail: Doran.Rozen@syneron.com


No publications provided


Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT01348776     History of Changes
Other Study ID Numbers: OHR-2
Study First Received: May 2, 2011
Results First Received: December 27, 2012
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration