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Collagenase in the Treatment of Cellulite
This study is not yet open for participant recruitment.
Study NCT00261144   Information provided by Stony Brook University
First Received: November 30, 2005   Last Updated: October 16, 2009   History of Changes

November 30, 2005
October 16, 2009
January 2010
January 2011   (final data collection date for primary outcome measure)
Reduction and/or elimination of cellulite in the posterolateral thigh [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Reduction and/or elimination of cellulite in the posterolateral thigh
Complete list of historical versions of study NCT00261144 on ClinicalTrials.gov Archive Site
 
 
 
Collagenase in the Treatment of Cellulite
Collagenase in the Treatment of Cellulite

The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.

This is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Cellulite
Drug: Collagenase
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
20
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 10 x 10 cm area of cellulite of the posterolateral thigh(s)

Exclusion Criteria:

  • any chronic, serious or uncontrolled medical condition
  • inability to conform to study visits (12-15 per year)
Both
18 Years to 70 Years
Yes
Contact: Marie A Badalamente, PhD 631 444 2215 mbadalamente@notes.cc.sunysb.edu
Contact: Gail Trocchio 631 444 2215 gtrocchio@notes.cc.sunysb.edu
United States
 
NCT00261144
Principal Investigator, SUNY Stony Brook, NY
Cell 101
Stony Brook University
Biospecifics Technologies Corp.
Principal Investigator: Marie A Badalamente, PhD Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
Principal Investigator: Alexander B Dagum, MD Dept. Surgery, SUNY@Stony Brook, NY 11794
Stony Brook University
October 2009

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