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Cellulite and Magnetic Resonance Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636025
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : February 26, 2015
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology

Brief 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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging
Study Start Date : July 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. The presence and characteristics of the fibrous septa in areas with and without cellulite. [ Time Frame: at baseline ]
    image from MRI

Secondary Outcome Measures :
  1. The characteristics of the subcutaneous tissue in areas with and without cellulite. [ Time Frame: at baseline ]
    image from MRI

Biospecimen Retention:   None Retained
None retained

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Females patients with cellulite on the buttocks.

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.

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Responsible Party: Doris Hexsel, Dr. Doris Hexsel and Brazilan Center for Studies in Dermatology, Brazilan Center for Studies in Dermatology Identifier: NCT00636025     History of Changes
Other Study ID Numbers: 02-CBED07-04
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms