Anatomy of Subcutaneous Structures in Areas With and Without Cellulite Depressions by Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- The presence and characteristics of the fibrous septa in areas with and without cellulite.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The presence and characteristics of the fibrous septa in areas with and without cellulite.
时间窗: at baseline
image from MRI
次要结局
- The characteristics of the subcutaneous tissue in areas with and without cellulite.(at baseline)
研究者
Doris Hexsel
Dr. Doris Hexsel and Brazilan Center for Studies in Dermatology
Brazilan Center for Studies in Dermatology