NCT03556917

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universidade Norte do Paraná · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Caffeine
• Cellulitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	iontophoresis + caffeine	we will use cafeislaine c (caffeine) +galvanic current

Timeline

• Start date: 2018-06-14
• Primary completion: 2019-03-17
• Completion: 2019-04-04
• First posted: 2018-06-14
• Last updated: 2019-04-16

Locations

1 site across 1 country: Brazil