Caffeine Clinical Trial
Official title:
The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
Verified date | April 2019 |
Source | Universidade Norte do Paraná |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 4, 2019 |
Est. primary completion date | March 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Rodrigo Antonio Carvalho Andraus | Londrina | Paraná |
Lead Sponsor | Collaborator |
---|---|
Universidade Norte do Paraná |
Brazil,
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. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | thickness | change from baseline subcutaneous adipose tissue thickness at after 10 sessions | through study completion, an average of 1 year. | |
Secondary | temperature | change from baseline superficial temperature of the gluteous skin at after 10 sessions | through study completion, an average of 1 year. | |
Secondary | 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. |
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