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The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556917
Recruitment Status : Completed
First Posted : June 14, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alana Roberta Quessada, Universidade Norte do Paraná

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.

Condition or disease Intervention/treatment Phase
Caffeine Cellulitis Combination Product: iontophoresis + caffeine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: It is a longitudinal and randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
Actual Study Start Date : June 14, 2018
Actual Primary Completion Date : March 17, 2019
Actual Study Completion Date : April 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Cellulitis

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




Primary Outcome Measures :
  1. thickness [ Time Frame: through study completion, an average of 1 year. ]
    change from baseline subcutaneous adipose tissue thickness at after 10 sessions


Secondary Outcome Measures :
  1. temperature [ Time Frame: through study completion, an average of 1 year. ]
    change from baseline superficial temperature of the gluteous skin at after 10 sessions

  2. score quality of life [ Time Frame: through study completion, an average of 1 year. ]
    change from baseline quality of life impact in patients with cellulits at after 10 sessions



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556917


Locations
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Brazil
Rodrigo Antonio Carvalho Andraus
Londrina, Paraná, Brazil, 86.041-140
Sponsors and Collaborators
Universidade Norte do Paraná
Investigators
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Principal Investigator: Rodrigo A Andraus Universidade Norte do Paraná
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Alana Roberta Quessada, Master student, Universidade Norte do Paraná
ClinicalTrials.gov Identifier: NCT03556917    
Other Study ID Numbers: 2.264.773
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents