The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2019-04-04

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.

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Detailed Description

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Conditions

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Caffeine Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

It is a longitudinal and randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

topical gel base + caffeine.

Group Type ACTIVE_COMPARATOR

iontophoresis + caffeine

Intervention Type COMBINATION_PRODUCT

we will use cafeislaine c (caffeine) +galvanic current

group 2

iontophoresis + caffeine

Group Type ACTIVE_COMPARATOR

iontophoresis + caffeine

Intervention Type COMBINATION_PRODUCT

we will use cafeislaine c (caffeine) +galvanic current

Group 3

iontophoresis

Group Type ACTIVE_COMPARATOR

iontophoresis + caffeine

Intervention Type COMBINATION_PRODUCT

we will use cafeislaine c (caffeine) +galvanic current

Interventions

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iontophoresis + caffeine

we will use cafeislaine c (caffeine) +galvanic current

Intervention Type COMBINATION_PRODUCT

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes