Hair Count Reduction Verification Study With the LightSheer Duet HS Handpiece

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.
ClinicalTrials.gov Identifier:
NCT01282866
First received: January 9, 2011
Last updated: February 20, 2014
Last verified: January 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hair Removal
Intervention: Device: LightSheer Duet

  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
No text entered.

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
HS Treatment

Treatment with the LightSheer Duet laser HS handpiece:

Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.

All patients were treated in the Axilla area.


Participant Flow:   Overall Study
    HS Treatment  
STARTED     35  
COMPLETED     34  
NOT COMPLETED     1  
Adverse Event                 1  



  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.
The power calculation proposed a sample of 35 participants to be sufficient to obtain qualitative assessment of of hair removal, as well as the qualitative assessment of treatment time and pain experienced during treatment with the LightSheer Duet HS handpiece.

Reporting Groups
  Description
HS Treatment

Treatment with the LightSheer Duet laser HS handpiece:

Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.

All patients were treated in the Axilla area.


Baseline Measures
    HS Treatment  
Number of Participants  
[units: participants]
  35  
Age  
[units: years]
Mean ± Standard Deviation
  30.9  ± 10  
Gender  
[units: participants]
 
Female     35  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     35  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hair Count   [ Time Frame: 6 month following last treatment ]

2.  Secondary:   Treatment Time   [ Time Frame: Each treatment ]

3.  Secondary:   Hair Count   [ Time Frame: 15 month following last treatment ]

4.  Secondary:   Level of Comfort Associated With Treatment   [ Time Frame: Each treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 NOT 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.


Results Point of Contact:  
Name/Title: Suzanne Kilmer, MD
Organization: Laser & Skin Surgery Medical Group Inc.
phone: 916-456-0400
e-mail: Study@skinlasers.com


No publications provided


Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT01282866     History of Changes
Other Study ID Numbers: LUM- ABU-LSDuet-08-001
Study First Received: January 9, 2011
Results First Received: January 6, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board