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Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00891774
First received: April 30, 2009
Last updated: October 4, 2011
Last verified: October 2011
Results First Received: April 15, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Therapeutic Body Modification
Intervention: Device: EVOLENCE®

  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
Device Treatment with EVOLENCE®

Participant Flow:   Overall Study
    Device  
STARTED     172  
COMPLETED     158  
NOT COMPLETED     14  
Lost to Follow-up                 5  
Illness (Self/Mother)                 3  
Withdrawal by Subject                 2  
Protocol Violation                 4  



  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
Device Treatment with EVOLENCE®

Baseline Measures
    Device  
Number of Participants  
[units: participants]
  172  
Age  
[units: years]
Mean ± Standard Deviation
  51.4  ± 10.28  
Gender  
[units: participants]
 
Female     150  
Male     22  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     18  
Not Hispanic or Latino     154  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     4  
Asian     6  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     135  
White     17  
More than one race     0  
Unknown or Not Reported     10  
Region of Enrollment  
[units: participants]
 
United States     172  
Fitzpatrick Skin Tone  
[units: Participants]
 
IV (Light Brown)     54  
V (Brown)     66  
VI (Dark Brown/Black)     52  



  Outcome Measures

1.  Primary:   Safety Endpoint   [ Time Frame: 6 months post injection ]

2.  Secondary:   Reduction in Wrinkle Severity Score   [ Time Frame: Baseline, 1, 3 and 6 months post injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Investigator’s Satisfaction of the Overall Treatment   [ Time Frame: 1, 3 and 6 months post injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Subject’s Satisfaction of the Overall Treatment   [ Time Frame: 1, 3 and 6 months post injection ]
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
This was not a controlled trial and the company made a business decision to discontinue marketing the product in the US, so the program has been terminated. No analysis will be performed on Secondary Outcome Measures.


  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: Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com


No publications provided


Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00891774     History of Changes
Obsolete Identifiers: NCT00871988
Other Study ID Numbers: DP101 US-04
Study First Received: April 30, 2009
Results First Received: April 15, 2011
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration