[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
Sponsor:
Information provided by:
[Redacted]
ClinicalTrials.gov Identifier:
NCT00764452
First received: September 30, 2008
Last updated: May 3, 2012
Last verified: NA

September 30, 2008
May 3, 2012
February 2006
Not Provided
Not Provided
  • Time-point measured [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Global Aesthetic Improvement Score per subject - Week 16 compared to un-treated [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Global Aesthetic Improvement Score per blinded photo review - Week 16 compared to untreated [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00764452 on ClinicalTrials.gov Archive Site
Not Provided
  • GAIS per investigator and subject - all time points (Post-treatment 72hrs, 2wks, 8wks, 16wks, 24wks, 32wks, 48wks) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Product palpability per investigator - all time points [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Global Aesthetic Improvement Score per subject - all other time points [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
[Trial of device that is not approved or cleared by the U.S. FDA]
[Trial of device that is not approved or cleared by the U.S. FDA]
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withheld
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00764452
MA-1800-30, IDE G060049
Not Provided
[Redacted]
[Redacted]
Not Provided
Not Provided
[Redacted]
Not Provided

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP