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Collagenase in the Treatment of Cellulite

Primary Purpose

Cellulite

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Collagenase

Biological

About this trial

This is an interventional treatment trial for Cellulite

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Dept. Orthopaedics, SUNY Stony Brook

Outcomes

Primary Outcome Measures

Reduction and/or elimination of cellulite in the posterolateral thigh

Secondary Outcome Measures

Full Information

NCT ID

NCT00261144

First Posted

November 30, 2005

Last Updated

December 11, 2012

Sponsor

Stony Brook University

1. Study Identification

Unique Protocol Identification Number

NCT00261144

Brief Title

Collagenase in the Treatment of Cellulite

Official Title

Collagenase in the Treatment of Cellulite

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

February 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stony Brook University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cellulite

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Collagenase

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Biological

Other Intervention Name(s)

Collagenase

Intervention Description

Collagenase injection

Primary Outcome Measure Information:

Title

Reduction and/or elimination of cellulite in the posterolateral thigh

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie A Badalamente, PhD

Phone

631 444 2215

Marie.Badalamente@stonybrookmedicine.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Gail Trocchio

Phone

631 444 2215

Gail.Trocchio@stonybrookmedicine.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie A Badalamente, PhD

Organizational Affiliation

Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alexander B Dagum, MD

Organizational Affiliation

Dept. Surgery, SUNY@Stony Brook, NY 11794

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. Orthopaedics, SUNY Stony Brook

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie A Badalamente, PhD

Phone

631-444-2215

Marie.Badalamente@stonybrookmedicine.edu

First Name & Middle Initial & Last Name & Degree

Gail Trocchio

Phone

631 444 2215

Gail.Trocchio@stonybrookmedicine.edu

First Name & Middle Initial & Last Name & Degree

Marie A Badalamente, PhD

First Name & Middle Initial & Last Name & Degree

Alexander B Dagum, MD

12. IPD Sharing Statement

Learn more about this trial

Collagenase in the Treatment of Cellulite

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