The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Conditions
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Caffeine, Cellulitis

Intervention / Treatment
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* Combination Product: iontophoresis + caffeine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: It is a longitudinal and randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>topical gel base + caffeine. | Combination Product: iontophoresis + caffeine<br>* we will use cafeislaine c (caffeine) +galvanic current<br>|
| Active Comparator: group 2<br>iontophoresis + caffeine | Combination Product: iontophoresis + caffeine<br>* we will use cafeislaine c (caffeine) +galvanic current<br>|
| Active Comparator: Group 3<br>iontophoresis | Combination Product: iontophoresis + caffeine<br>* we will use cafeislaine c (caffeine) +galvanic current<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness | change from baseline subcutaneous adipose tissue thickness at after 10 sessions | through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| temperature | change from baseline superficial temperature of the gluteous skin at after 10 sessions | through study completion, an average of 1 year. | 
| score quality of life | change from baseline quality of life impact in patients with cellulits at after 10 sessions | through study completion, an average of 1 year. |