Cellulite and Magnetic Resonance Imaging

Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging

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.

Study Overview

• Status: Completed
• Conditions: Cellulitis

Detailed Description

A cross-sectional study was performed at a single center, in accordance with good clinical practice. Thirty women aged 18 to 50 were included in this study. An experienced dermatologist evaluated all of the subjects in a standing position, with relaxed gluteus muscles, using the CSS classification. An area with cellulite and another without cellulite on the contralateral buttock were selected. The area with cellulite had an evident depressed lesion, whereas the area without cellulite had no depressed or raised lesions, The selected cellulite depression was marked with a positive symbol using a skin marking pen.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Females patients with cellulite on the buttocks.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence and characteristics of the fibrous septa in areas with and without cellulite.	image from MRI	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The characteristics of the subcutaneous tissue in areas with and without cellulite.	image from MRI	at baseline

Collaborators and Investigators

• Sponsor: Doris Hexsel

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 13, 2008
• First Posted (Estimate): March 14, 2008

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Connective Tissue Diseases; Skin Diseases, Infectious; Skin Manifestations; Suppuration; Cellulitis; Cellulite
• Other Study ID Numbers: 02-CBED07-04