Collagenase in the Treatment of Cellulite

This study is not yet open for participant recruitment.

Verified August 2011 by Stony Brook University

First Received on November 30, 2005. Last Updated on August 16, 2011 History of Changes

Sponsor:	Stony Brook University
Collaborator:	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:	Allocation: Randomized 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 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Intervention Details:

One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)

Detailed Description:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Responsible Party:	Principal Investigator, SUNY Stony Brook, NY
ClinicalTrials.gov Identifier:	NCT00261144 History of Changes
Other Study ID Numbers:	Cell 101
Study First Received:	November 30, 2005
Last Updated:	August 16, 2011
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 12, 2012