Collagenase in the Treatment of Cellulite

Cellulite Clinical Trial

Official title:

Collagenase in the Treatment of Cellulite

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00261144
• Other study ID #: Cell 101
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 30, 2005
• Last updated: December 11, 2012
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2012
• Source: Stony Brook University
• Contact: Marie A Badalamente, PhD
• Phone: 631 444 2215
• Email: Marie.Badalamente[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cellulite

Intervention

Drug:
• Collagenase
One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)

Biological:
• Biological
Collagenase injection

Locations

Country	Name	City	State
United States	Dept. Orthopaedics, SUNY Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction and/or elimination of cellulite in the posterolateral thigh		6 months	Yes