- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261144
Collagenase in the Treatment of Cellulite
December 11, 2012 updated by: Marie A. Badalamente, Stony Brook University
The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie A Badalamente, PhD
- Phone Number: 631 444 2215
- Email: Marie.Badalamente@stonybrookmedicine.edu
Study Contact Backup
- Name: Gail Trocchio
- Phone Number: 631 444 2215
- Email: Gail.Trocchio@stonybrookmedicine.edu
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Dept. Orthopaedics, SUNY Stony Brook
-
Contact:
- Gail Trocchio
- Phone Number: 631 444 2215
- Email: Gail.Trocchio@stonybrookmedicine.edu
-
Contact:
- Marie A Badalamente, PhD
- Phone Number: 631-444-2215
- Email: Marie.Badalamente@stonybrookmedicine.edu
-
Principal Investigator:
- Marie A Badalamente, PhD
-
Principal Investigator:
- Alexander B Dagum, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction and/or elimination of cellulite in the posterolateral thigh
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander B Dagum, MD, Dept. Surgery, SUNY@Stony Brook, NY 11794
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ANTICIPATED)
February 1, 2014
Study Completion (ANTICIPATED)
March 1, 2014
Study Registration Dates
First Submitted
November 30, 2005
First Submitted That Met QC Criteria
December 1, 2005
First Posted (ESTIMATE)
December 2, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
December 12, 2012
Last Update Submitted That Met QC Criteria
December 11, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cell 101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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