Cellulite and Magnetic Resonance Imaging

Cellulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636025
• Other study ID #: 02-CBED07-04
• Status: Completed
• Phase: N/A
• First received: March 11, 2008
• Last updated: February 24, 2015
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2015
• Source: Brazilan Center for Studies in Dermatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cellulitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Doris Hexsel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence and characteristics of the fibrous septa in areas with and without cellulite.	image from MRI	at baseline	Yes
Secondary	The characteristics of the subcutaneous tissue in areas with and without cellulite.	image from MRI	at baseline	Yes