NCT02195297已完成3 期
Clinical and Instrumental Evaluation of the Activity of a Pharmacological "Anticellulitis" Product vs. a Reference Product on the Market: Comparison Within Subjects (Double Blind Study)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 22
- 主要终点
- Morphometric evaluations: change from baseline (T2 and T4 vs. T0)
研究概览
简要总结
Aim of this study was to evaluate by clinical, morphometric and non invasive instrumental evaluations the activity of an "anticellulitis" cosmetic product vs a reference product of the market (comparison within subjects), applied once a day, for an uninterrupted period of 4 weeks, on 22 female healthy volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs.
It was also aim of the study to evaluate cosmetic acceptability by the volunteers and products efficacy and tolerance both by investigator and volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •female volunteers
- •volunteers aged more than 18 years old
- •volunteers with low/moderate oedematous - fibrosclerotic lipodystrophy on the thighs
- •volunteers with no weight variation (± 1.5 kg) during the last month preceding the study inclusion
- •volunteers with regular menstrual cycle (28-32 days) or in menopause from at least 2 years
- •volunteers who are giving a written informed consent.
排除标准
- •pregnancy
- •lactation
- •smoke (admitted 10 cigarettes/day)
- •assumption of alcoholic drinks/wine/beer (admitted up to 125 ml for meal)
- •oral contraceptive/replacement therapy started less than 1 year ago
- •alimentary diet
- •change in the normal habits in the last month (unusual physical activity)
- •use of any product or weight-loss treatment (manual or instrumental massage) on skin test areas during the last month
- •use of any drug able to cause a weight body variation
- •presence of clinically important vascular disorders
- •insufficient adhesion to the study protocol and to the treatment
- •participation in a similar study during the previous month
- •dermatological disease
- •clinical and significant skin condition on the test area (e.g. lesions, scars, malformations)
- •suspect thyroid disfunction
- •thyroid disorders/diseases
- •other endocrine diseases as diabetes, metabolic disorders etc.
- •hepatic, renal or cardiac disorder
- •topical drugs or surgical procedure on the test areas during the previous 3 months
- •systemic corticosteroids
- •aspirin or non-steroid anti-inflammatory drugs (FANS)
- •diuretic drugs
结局指标
主要结局
Morphometric evaluations: change from baseline (T2 and T4 vs. T0)
时间窗: after 2 and 4 week-treatment
All the measures were performed in standard conditions at level of the thigh (III superior, III middle and inferior), thanks to a specific electro-optical system.
次要结局
- Skin plastoelasticity: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Thermography evaluation: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Ultrasonographic evaluations: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Optical densitometry: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Clinical evaluations: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
- Tissue dielectric constant of deep skin layers: change from baseline (T2 and T4 vs. T0)(after 2 and 4 week-treatment)
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