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Collagenase in the Treatment of Cellulite

This study is not yet open for participant recruitment.
Verified December 2012 by Stony Brook University
Sponsor:
Information provided by (Responsible Party):
Marie A. Badalamente, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00261144
First received: November 30, 2005
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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
Biological: Biological
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Collagenase in the Treatment of Cellulite

Resource links provided by NLM:

Drug Information available for: Collagenase
U.S. FDA Resources

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Reduction and/or elimination of cellulite in the posterolateral thigh [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Collagenase
    One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)
    Biological: Biological
    Collagenase injection
    Other Name: Collagenase
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 Marie.Badalamente@stonybrookmedicine.edu
Contact: Gail Trocchio 631 444 2215 Gail.Trocchio@stonybrookmedicine.edu

Locations
United States, New York
Dept. Orthopaedics, SUNY Stony Brook Not yet recruiting
Stony Brook, New York, United States, 11794
Contact: Marie A Badalamente, PhD     631-444-2215     Marie.Badalamente@stonybrookmedicine.edu    
Contact: Gail Trocchio     631 444 2215     Gail.Trocchio@stonybrookmedicine.edu    
Principal Investigator: Marie A Badalamente, PhD            
Principal Investigator: Alexander B Dagum, MD            
Sponsors and Collaborators
Stony Brook University
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

Responsible Party: Marie A. Badalamente, Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT00261144     History of Changes
Other Study ID Numbers: Cell 101
Study First Received: November 30, 2005
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013