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The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03556917
Enrollment
30
Registered
2018-06-14
Start date
2018-06-14
Completion date
2019-04-04
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caffeine, Cellulitis

Brief 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.

Interventions

COMBINATION_PRODUCTiontophoresis + caffeine

we will use cafeislaine c (caffeine) +galvanic current

Sponsors

Universidade Norte do Paraná
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

It is a longitudinal and randomized

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
thicknessthrough study completion, an average of 1 year.change from baseline subcutaneous adipose tissue thickness at after 10 sessions

Secondary

MeasureTime frameDescription
temperaturethrough study completion, an average of 1 year.change from baseline superficial temperature of the gluteous skin at after 10 sessions
score quality of lifethrough study completion, an average of 1 year.change from baseline quality of life impact in patients with cellulits at after 10 sessions

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026