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
  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

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 April 15, 2014