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Safety for Frequent Use Conditions of Hair Removal Device (OHR-3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348789
First Posted: May 5, 2011
Last Update Posted: February 18, 2013
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.
Information provided by (Responsible Party):
Syneron Medical
Results First Submitted: December 4, 2012  
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
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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 January to June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hair2Go (Mē) Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals

Participant Flow:   Overall Study
    Hair2Go (Mē)
STARTED   37 
COMPLETED   33 [1] 
NOT COMPLETED   4 
Protocol Violation                2 
Withdrawal by Subject                2 
[1] 4 subjects did not complete all 3 treatments but were evaluated for primary and secondary endpoints.



  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.
No text entered.

Reporting Groups
  Description
Hair2Go (Mē) Treatment with Hair2Go (Mē)device

Baseline Measures
   Hair2Go (Mē) 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   37 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.5  (8.1) 
Gender 
[Units: Participants]
 
Female   29 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.   [ Time Frame: Up to 3 months ]

2.  Secondary:   Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.   [ Time Frame: 0, 3, 7 days (after treatment #1, #2, and #3 respectively) ]

3.  Secondary:   Hair Clearance   [ Time Frame: 8 weeks after last treatment ]


  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: Dr. Jerome M. Garden
Organization: Northwestern Memorial Hospital
phone: 312-280-0891
e-mail: j-garden@northwestern.edu



Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT01348789     History of Changes
Other Study ID Numbers: OHR-3
First Submitted: May 4, 2011
First Posted: May 5, 2011
Results First Submitted: December 4, 2012
Results First Posted: February 18, 2013
Last Update Posted: February 18, 2013