The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- thickness
研究概览
简要总结
Introduction: Gynoid hydrolipodystrophy (HLDG) or cellulitis is a subcutaneous tissue disorder, with several strategies for its treatment, such as caffeine and iontophoresis. Objective: To evaluate the effects of caffeine-associated iontophoresis for the treatment of HLDG. Methods: In a longitudinal study, participants will be evaluated for: photographic documentation, ultrasound imaging, thermography and quality of life questionnaire. If included, they will be separated into 3 randomized groups (n = 30). G1: use of base gel (n = 10); G2: use of iontophoresis and gel with caffeine (n = 10) and G3: use of iontophoresis alone (n = 10). The groups will be treated with 10 sessions, 2 times per week. After that they will be reevaluated. Statistical analysis: The software used will be the SPSS StatisticalPackage (IBM SPSS Statistics, Chicago, IL, USA). The data distribution will be analyzed by the Shapiro-Wilk test. In case of normal distribution, the data will be described as mean ± standard deviation; otherwise, as median [interquartile range 25-75%]. For comparison of the data, we will use ANOVA and for comparison of means the Tukey test and case not normal distribution, krulskal-Wallis test and the Dunns test. The level of statistical significance adopted will be P <0.05. Expected contributions: It is expected that investigators can contribute to the treatment of patients with HLDG and analyze the effects of iontophoresis with caffeine, both in clinical and scientific practice, providing a method that is valid and reliable for this purpose; multidisciplinary training of highly qualified human resources and the strengthening and consolidation of a research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with mild to moderate cellulite diagnosis will be included, according to the validated Photonumeric scale of cellulite severity
- •Body mass index less than 30 (kg / m2)
排除标准
- •Individuals who have a deregulated menstrual cycle who are pregnant;
- •Breastfeeding or using some hormone;
- •Antibiotic medication including steroids over 1 month of treatment of skin diseases; •Sensitivity or hypersensitivity of the skin;
- •Use of the same or similar cosmetics or remedies on the glutes within 1 month;
- •Surgical procedure (liposuction and skin treatments) in the region to be treated or planning some procedure within the study period;
- •Chronic debilitating diseases such as asthma, diabetes or hypertension;
- •Atopic dermatitis
研究组 & 干预措施
group 1
topical gel base + caffeine.
干预措施: iontophoresis + caffeine (Combination Product)
group 2
iontophoresis + caffeine
干预措施: iontophoresis + caffeine (Combination Product)
Group 3
iontophoresis
干预措施: iontophoresis + caffeine (Combination Product)
结局指标
主要结局
thickness
时间窗: through study completion, an average of 1 year.
change from baseline subcutaneous adipose tissue thickness at after 10 sessions
次要结局
- temperature(through study completion, an average of 1 year.)
- score quality of life(through study completion, an average of 1 year.)
研究者
Alana Roberta Quessada
Master student
Universidade Norte do Paraná
