Cellulitis Clinical Trial
Official title:
Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging
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 |
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.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Doris Hexsel |
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 |
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