Collagenase in the Treatment of Cellulite

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Stony Brook University.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Marie A. Badalamente, Stony Brook University Identifier:
First received: November 30, 2005
Last updated: December 11, 2012
Last verified: December 2012
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
Drug: Collagenase
Biological: Biological
Phase 2

Study Type: Interventional
Study Design: 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 ]

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00261144

United States, New York
Dept. Orthopaedics, SUNY Stony Brook
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
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

Responsible Party: Marie A. Badalamente, Professor, Stony Brook University Identifier: NCT00261144     History of Changes
Other Study ID Numbers: Cell 101 
Study First Received: November 30, 2005
Last Updated: December 11, 2012 processed this record on January 19, 2017