Cellulite and Magnetic Resonance Imaging - Full Text View

Sponsored by:	Brazilian Center for Dermatological Studies
Information provided by:	Brazilian Center for Dermatological Studies
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

MedlinePlus related topics: Anatomy MRI Scans

U.S. FDA Resources

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

Further study details as provided by Brazilian Center for Dermatological Studies:

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

Biospecimen Description:

None retained

Enrollment:

30

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

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

Study placed in the following topic categories:

Depression
Depressive Disorder

ClinicalTrials.gov processed this record on January 16, 2009