Collagenase in the Treatment of Cellulite

This study is not yet open for participant recruitment.

Verified by Stony Brook University, October 2009

First Received: November 30, 2005 Last Updated: October 16, 2009 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Collagenase in the Treatment of Cellulite

Resource links provided by NLM:

Drug Information available for: Collagenase

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:	January 2010
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (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
Stony Brook, New York, United States, 11794

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:	SUNY Stony Brook, NY ( Principal Investigator )
Study ID Numbers:	Cell 101
Study First Received:	November 30, 2005
Last Updated:	October 16, 2009
ClinicalTrials.gov Identifier:	NCT00261144 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 09, 2009