The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Caffeine Clinical Trial

Official title:

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556917
• Other study ID #: 2.264.773
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 14, 2018
• Est. completion date: April 4, 2019

Study information

• Verified date: April 2019
• Source: Universidade Norte do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Caffeine
• Cellulitis

Intervention

Combination Product:
• iontophoresis + caffeine
we will use cafeislaine c (caffeine) +galvanic current

Locations

Country	Name	City	State
Brazil	Rodrigo Antonio Carvalho Andraus	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Norte do Paraná

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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

Outcome

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.