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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 Marie A. Badalamente, Stony Brook University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261144
First Posted: December 2, 2005
Last Update Posted: December 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marie A. Badalamente, Stony Brook University
  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: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Collagenase in the Treatment of Cellulite

Further study details as provided by Marie A. Badalamente, 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Marie A. Badalamente, Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT00261144     History of Changes
Other Study ID Numbers: Cell 101
First Submitted: November 30, 2005
First Posted: December 2, 2005
Last Update Posted: December 12, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Cellulite
Skin Manifestations
Signs and Symptoms