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临床试验/NCT03556917
NCT03556917已完成2 期

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Universidade Norte do Paraná2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年6月14日最近更新:
适应症
干预措施

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

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

Active Comparator

topical gel base + caffeine.

干预措施: iontophoresis + caffeine (Combination Product)

group 2

Active Comparator

iontophoresis + caffeine

干预措施: iontophoresis + caffeine (Combination Product)

Group 3

Active Comparator

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

发起方
Universidade Norte do Paraná
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alana Roberta Quessada

Master student

Universidade Norte do Paraná

研究点 (2)

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