NCT00261144

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
7.2 years until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

November 30, 2005

Last Update Submit

December 11, 2012

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

  • Reduction and/or elimination of cellulite in the posterolateral thigh

    6 months

Interventions

CollagenaseDRUG

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

BiologicalBIOLOGICAL

Collagenase injection

Also known as: Collagenase

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • x 10 cm area of cellulite of the posterolateral thigh(s)

You may not qualify if:

  • any chronic, serious or uncontrolled medical condition
  • inability to conform to study visits (12-15 per year)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Orthopaedics, SUNY Stony Brook

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Cellulite

Interventions

CollagenasesBiological Products

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesComplex Mixtures

Study Officials

  • 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

Central Study Contacts

Marie A Badalamente, PhD

CONTACT

631 444 2215Marie.Badalamente@stonybrookmedicine.edu

Gail Trocchio

CONTACT

631 444 2215Gail.Trocchio@stonybrookmedicine.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

US(1)