Cellulite and Magnetic Resonance Imaging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT00636025
First received: March 11, 2008
Last updated: February 24, 2015
Last verified: February 2015
  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
Cellulitis

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

Resource links provided by NLM:


Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • The presence and characteristics of the fibrous septa in areas with and without cellulite. [ Time Frame: at baseline ] [ Designated as safety issue: Yes ]
    image from MRI


Secondary Outcome Measures:
  • The characteristics of the subcutaneous tissue in areas with and without cellulite. [ Time Frame: at baseline ] [ Designated as safety issue: Yes ]
    image from MRI


Biospecimen Retention:   None Retained

None retained


Enrollment: 30
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Doris Hexsel, Dr. Doris Hexsel and Brazilan Center for Studies in Dermatology, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT00636025     History of Changes
Other Study ID Numbers: 02-CBED07-04
Study First Received: March 11, 2008
Last Updated: February 24, 2015
Health Authority: Brazil: Ministry of Health

ClinicalTrials.gov processed this record on March 30, 2015