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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01348776
Recruitment Status : Completed
First Posted : May 5, 2011
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
Syneron Medical

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hair Removal
Intervention: Device: Hair2Go (Mē)

  Participant Flow

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
Hair2Go (Me) Subjects treated with the Hair2Go (Me) Device

Participant Flow:   Overall Study
    Hair2Go (Me)
STARTED   87 [1] 
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

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.
No text entered.

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

Baseline Measures
   Hair2Go (Me) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   87 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 36.4  (9) 
[Units: Participants]
Female   79 
Male   8 
Region of Enrollment 
[Units: Participants]
United States   87 

  Outcome Measures

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

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
No text entered.

  More Information

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

Responsible Party: Syneron Medical Identifier: NCT01348776     History of Changes
Other Study ID Numbers: OHR-2
First Submitted: May 2, 2011
First Posted: May 5, 2011
Results First Submitted: December 27, 2012
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013