The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

NCT03556917 | Completed Phase 2 DMC

• 1 other identifier: 2.264.773
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Caffeine; Cellulitis

Outcome Measures

Primary Outcomes (1)

• thickness

  change from baseline subcutaneous adipose tissue thickness at after 10 sessions

  through study completion, an average of 1 year.

Secondary Outcomes (2)

• temperature

  through study completion, an average of 1 year.

• score quality of life

  through study completion, an average of 1 year.

Study Arms (3)

group 1

ACTIVE COMPARATOR

topical gel base + caffeine.

Combination Product: iontophoresis + caffeine

group 2

ACTIVE COMPARATOR

iontophoresis + caffeine

Combination Product: iontophoresis + caffeine

Group 3

ACTIVE COMPARATOR

iontophoresis

Combination Product: iontophoresis + caffeine

Interventions

iontophoresis + caffeine COMBINATION_PRODUCT

we will use cafeislaine c (caffeine) +galvanic current

Group 3; group 1; group 2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Rodrigo Antonio Carvalho Andraus

Londrina, Paraná, 86.041-140, Brazil

Location

Related 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.

  PMID: 19220646 RESULT

• 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.

  PMID: 24010809 RESULT

MeSH Terms

Conditions

Cellulitis

Interventions

Iontophoresis; Caffeine

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rodrigo A Andraus

  Universidade Norte do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Model Details: It is a longitudinal and randomized

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 14, 2018
• Study Start: June 14, 2018
• Primary Completion: March 17, 2019
• Study Completion: April 4, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)