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Trial record 1 of 1 for:    gel-del
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Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414544
First Posted: December 21, 2006
Last Update Posted: June 27, 2011
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.
Collaborator:
Cosmeta Corp, A Gel-Del Technologies Company
Information provided by:
Cosmeta
Results First Submitted: March 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Facial Wrinkles
Interventions: Device: CosmetaLife
Device: Restylane

  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
CosmetaLife vs Restylane Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.

Participant Flow:   Overall Study
    CosmetaLife vs Restylane
STARTED   145 
COMPLETED   131 
NOT COMPLETED   14 
Lost to Follow-up                14 



  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
CosmetaLife vs Restylane Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.

Baseline Measures
   CosmetaLife vs Restylane 
Overall Participants Analyzed 
[Units: Participants]
 145 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   122 
>=65 years   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.9  (10.0) 
Gender 
[Units: Participants]
 
Female   135 
Male   10 
Region of Enrollment 
[Units: Participants]
 
United States   145 


  Outcome Measures

1.  Primary:   Change in Wrinkle Severity Rating Scale   [ Time Frame: baseline and 6 months ]

2.  Primary:   Adverse Event Reporting   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months   [ Time Frame: 3, 9 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: Dr. David B. Masters
Organization: Cosmeta, A Gel-Del Technolgies Company
phone: 651 209-0707
e-mail: dmasters@gel-del.com



Responsible Party: David B. Masters/President, Cosmeta Corp, A Gel-Del Technologies Company
ClinicalTrials.gov Identifier: NCT00414544     History of Changes
Other Study ID Numbers: CosmetaLife 1
First Submitted: December 20, 2006
First Posted: December 21, 2006
Results First Submitted: March 4, 2011
Results First Posted: June 10, 2011
Last Update Posted: June 27, 2011