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Completed

NCT Number: NCT03556917

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

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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Key information

Conditions

Caffeine Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rodrigo Antonio Carvalho Andraus

Londrina, Paraná, 86.041-140, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iontophoresis + caffeine

Combination Product

we will use cafeislaine c (caffeine) +galvanic current

Primary outcomes

  1. thickness

    Time frame: through study completion, an average of 1 year.

    change from baseline subcutaneous adipose tissue thickness at after 10 sessions

Secondary outcomes

  1. temperature

    Time frame: through study completion, an average of 1 year.

    change from baseline superficial temperature of the gluteous skin at after 10 sessions

  2. score quality of life

    Time frame: through study completion, an average of 1 year.

    change from baseline quality of life impact in patients with cellulits at after 10 sessions

Sponsors and collaborators

Lead sponsor

Universidade Norte do Paraná

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2018
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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