The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Universidade Norte do Paraná

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cellulitis; Caffeine

Treatments: Combination Product: iontophoresis + caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT03556917

2.264.773

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

group 1

Active Comparator group

Description:

topical gel base + caffeine.

Treatment:

Combination Product: iontophoresis + caffeine

group 2

Active Comparator group

Description:

iontophoresis + caffeine

Treatment:

Combination Product: iontophoresis + caffeine

Group 3

Active Comparator group

Description:

iontophoresis

Treatment:

Combination Product: iontophoresis + caffeine