Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01618864
First received: June 11, 2012
Last updated: July 20, 2014
Last verified: July 2014
Results First Received: June 10, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Rosacea
Wrinkles
Intervention: Device: Luxe

  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
Luxe Treatment Group Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.

Participant Flow:   Overall Study
    Luxe Treatment Group  
STARTED     23  
Completed 2 Weeks     19  
COMPLETED     19 [1]
NOT COMPLETED     4  
Withdrawal by Subject                 2  
Lost to Follow-up                 2  
[1] Completed 4 weeks and 8 weeks of treatment



  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
Luxe Treatment Group Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.

Baseline Measures
    Luxe Treatment Group  
Number of Participants  
[units: participants]
  23  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     22  
>=65 years     1  
Gender  
[units: participants]
 
Female     19  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     23  



  Outcome Measures
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1.  Primary:   Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)   [ Time Frame: 4, 8 weeks ]

2.  Secondary:   Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale   [ Time Frame: 4, 8 weeks ]

3.  Secondary:   Reduction in Rosacea by the Study Investigator Using a Validated Scale   [ Time Frame: 4, 8 weeks ]


  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
Small number of subjects analyzed for post-marketing study.


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Clinical Affairs
Organization: Iluminage
phone: +972 547 800 260
e-mail: doranr@iluminagebeauty.com


No publications provided


Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT01618864     History of Changes
Other Study ID Numbers: Luxe01
Study First Received: June 11, 2012
Results First Received: June 10, 2014
Last Updated: July 20, 2014
Health Authority: United States: Institutional Review Board