Cellulite and Magnetic Resonance Imaging

This study has been terminated.

First Received on March 11, 2008. Last Updated on March 13, 2008 History of Changes

Sponsor:	Brazilan Center for Studies in Dermatology
Information provided by:	Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:	NCT00636025

Purpose

The purpose of this study is to compare the anatomy of subcutaneous structures in areas with and without cellulite on the buttocks of same subjects with a non invasive technique, Magnetic Resonance Imaging.

Condition
Cellulite

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging

Resource links provided by NLM:

MedlinePlus related topics: Anatomy MRI Scans

U.S. FDA Resources

Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:

The presence and characteristics of the fibrous septa in areas with and without cellulite. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The characteristics of the subcutaneous tissue in areas with and without cellulite. [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

None retained

Enrollment:

Groups/Cohorts
Observational

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Females patients with cellulite on the buttocks.

Criteria

Inclusion Criteria:

Written Informed Consent;
Subjects agreeing to take part of all procedures of the study, after being fully informed on the objectives and nature of the investigations;
Healthy female subjects over 18 years;
Subjects presenting cellulite on the buttocks;
Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
Female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method (3 months before the enrollment until the end of the study);
Availability of the subject throughout the duration of the study (180 days);
Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.

Exclusion Criteria:

Pregnant women or women intending to become pregnant during the study (next 3 months);
Subjects participating in other clinical trials;
Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Doris Hexsel, CBED
ClinicalTrials.gov Identifier:	NCT00636025 History of Changes
Other Study ID Numbers:	02-CBED07-04
Study First Received:	March 11, 2008
Last Updated:	March 13, 2008
Health Authority:	Brazil: Ministry of Health

ClinicalTrials.gov processed this record on February 09, 2012