Clinical trial NCT03556917: The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
Official title: The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Caffeine
Cellulitis
Lead sponsor: Universidade Norte do Paraná
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: It is a longitudinal and randomized
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: thickness
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
measure: temperature
timeFrame: through study completion, an average of 1 year.
measure: score quality of life
timeFrame: through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Rodrigo Antonio Carvalho Andraus
state: Paraná
Study officials:
affiliation: Universidade Norte do Paraná
name: Rodrigo A Andraus
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hexsel DM, Dal'forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad Dermatol Venereol. 2009 May;23(5):523-8. doi: 10.1111/j.1468-3083.2009.03101.x. Epub 2009 Feb 13.
citation: Yoo MA, Seo YK, Ryu JH, Back JH, Koh JS. A validation study to find highly correlated parameters with visual assessment for clinical evaluation of cosmetic anti-cellulite products. Skin Res Technol. 2014 May;20(2):200-7. doi: 10.1111/srt.12106. Epub 2013 Sep 7.