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.

Study Overview

• Status: Completed
• Conditions: Cellulitis; Caffeine
• Intervention / Treatment: Combination product: iontophoresis + caffeine

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86.041-140
      • Rodrigo Antonio Carvalho ANDRAUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1; topical gel base + caffeine.	Combination product: iontophoresis + caffeine; we will use cafeislaine c (caffeine) +galvanic current
Active Comparator: group 2; iontophoresis + caffeine	Combination product: iontophoresis + caffeine; we will use cafeislaine c (caffeine) +galvanic current
Active Comparator: Group 3; iontophoresis	Combination product: iontophoresis + caffeine; we will use cafeislaine c (caffeine) +galvanic current

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thickness	change from baseline subcutaneous adipose tissue thickness at after 10 sessions	through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
temperature	change from baseline superficial temperature of the gluteous skin at after 10 sessions	through study completion, an average of 1 year.
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.

Collaborators and Investigators

• Sponsor: Universidade Norte do Paraná
• Investigators: Principal Investigator: Rodrigo A Andraus, Universidade Norte do Paraná

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): March 17, 2019
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Cellulitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 2.264.773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Statistical Analysis Plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No