Collagenase in the Treatment of Cellulite

NCT ID: NCT00261144

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cellulite

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Collagenase

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

Intervention Type DRUG

Biological

Collagenase injection

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Collagenase

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marie A. Badalamente

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marie A Badalamente, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Alexander B Dagum, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. Surgery, SUNY@Stony Brook, NY 11794

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. Orthopaedics, SUNY Stony Brook

Stony Brook, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marie A Badalamente, PhD

Role: CONTACT

Phone: 631 444 2215

Email: [email protected]

Gail Trocchio

Role: CONTACT

Phone: 631 444 2215

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marie A Badalamente, PhD

Role: primary

Gail Trocchio

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cell 101

Identifier Type: -

Identifier Source: org_study_id