Collagenase in the Treatment of Cellulite | NCT00261144

Studies
Collagenase in the Treatment of Cellulite

NCT00261144

Sponsor

Stony Brook University

Status

Unknown status

Last Update Posted

Dec 12, 2012Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Cellulite

Interventions

Collagenase
Biological

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Nov 30, 2005

First Submission Date that Met QC Criteria

Dec 1, 2005

First Posted Date

Dec 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2012

Last Update Posted Date

Dec 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collagenase	Drug	One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)
Biological	Biological	Collagenase injection		Collagenase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction and/or elimination of cellulite in the posterolateral thigh		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marie A Badalamente, PhD	Contact	631 444 2215		Marie.Badalamente@stonybrookmedicine.edu
Gail Trocchio	Contact	631 444 2215		Gail.Trocchio@stonybrookmedicine.edu

Overall Officials

Name	Affiliation	Role
Marie A Badalamente, PhD	Dept. Orthopaedics, SUNY@Stony Brook, NY 11794	Principal Investigator
Alexander B Dagum, MD	Dept. Surgery, SUNY@Stony Brook, NY 11794	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Orthopaedics, SUNY Stony Brook		Stony Brook	New York	11794	United States

Condition Browse Module

MeSH Terms

ID	Term
D000071697	Cellulite

Ancestor Terms

ID	Term
D012877	Skin Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017364	Collagenases
D001688	Biological Products

Ancestor Terms

ID	Term
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided