Cellulite and Magnetic Resonance Imaging

NCT00636025 | Completed

• 1 other identifier: 02-CBED07-04
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cellulitis

Outcome Measures

Primary Outcomes (1)

• The presence and characteristics of the fibrous septa in areas with and without cellulite.

  image from MRI

  at baseline

Secondary Outcomes (1)

• The characteristics of the subcutaneous tissue in areas with and without cellulite.

  at baseline

Study Arms (1)

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Females patients with cellulite on the buttocks.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Doris Hexsel: lead

Biospecimen

Retention: NONE RETAINED

None retained

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Doris Hexsel and Brazilan Center for Studies in Dermatology

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 14, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: February 26, 2015

Record last verified: 2015-02