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Collagenase in the Treatment of Cellulite
This study is currently recruiting participants.
Verified by Stony Brook University, November 2005
First Received: November 30, 2005   Last Updated: December 6, 2005   History of Changes
Sponsors and Collaborators: Stony Brook University
Biospecifics Technologies Corp.
Information provided by: Stony Brook University
ClinicalTrials.gov Identifier: NCT00261144
  Purpose

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


Condition Intervention Phase
Cellulite
Drug: Collagenase
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Collagenase in the Treatment of Cellulite

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Reduction and/or elimination of cellulite in the posterolateral thigh

Estimated Enrollment: 10
Study Start Date: January 2005
Estimated Study Completion Date: March 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261144

Contacts
Contact: Marie A Badalamente, PhD 631 444 2215 mbadalamente@notes.cc.sunysb.edu
Contact: Gail Trocchio 631 444 2215 gtrocchio@notes.cc.sunysb.edu

Locations
United States, New York
Dept. Orthopaedics, SUNY Stony Brook Recruiting
Stony Brook, New York, United States, 11794
Contact: Marie A Badalamente, PhD     631-444-2215     mbadalamente@notes.cc.sunysb.edu    
Contact: Gail Trocchio     631 444 2215     gtrocchio@notes.cc.sunysb.edu    
Principal Investigator: Marie A Badalamente, PhD            
Principal Investigator: Alexander B Dagum, MD            
Sponsors and Collaborators
Stony Brook University
Biospecifics Technologies Corp.
Investigators
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
  More Information

No publications provided

Study ID Numbers: Cell 101
Study First Received: November 30, 2005
Last Updated: December 6, 2005
ClinicalTrials.gov Identifier: NCT00261144     History of Changes
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 02, 2009