Back to results

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Primary Purpose

Caffeine, Cellulitis

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

iontophoresis + caffeine

About this trial

This is an interventional treatment trial for Caffeine

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Rodrigo Antonio Carvalho Andraus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

group 1

group 2

Group 3

Arm Description

topical gel base + caffeine.

iontophoresis + caffeine

iontophoresis

Outcomes

Primary Outcome Measures

thickness

change from baseline subcutaneous adipose tissue thickness at after 10 sessions

Secondary Outcome Measures

temperature

change from baseline superficial temperature of the gluteous skin at after 10 sessions

score quality of life

change from baseline quality of life impact in patients with cellulits at after 10 sessions

Full Information

NCT ID

NCT03556917

First Posted

May 15, 2018

Last Updated

April 15, 2019

Sponsor

Universidade Norte do Paraná

1. Study Identification

Unique Protocol Identification Number

NCT03556917

Brief Title

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Official Title

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 14, 2018 (Actual)

Primary Completion Date

March 17, 2019 (Actual)

Study Completion Date

April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Norte do Paraná

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Caffeine, Cellulitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Factorial Assignment

Model Description

It is a longitudinal and randomized

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group 1

Arm Type

Active Comparator

Arm Description

topical gel base + caffeine.

Arm Title

group 2

Arm Type

Active Comparator

Arm Description

iontophoresis + caffeine

Arm Title

Group 3

Arm Type

Active Comparator

Arm Description

iontophoresis

Intervention Type

Combination Product

Intervention Name(s)

iontophoresis + caffeine

Intervention Description

we will use cafeislaine c (caffeine) +galvanic current

Primary Outcome Measure Information:

Title

thickness

Description

change from baseline subcutaneous adipose tissue thickness at after 10 sessions

Time Frame

through study completion, an average of 1 year.

Secondary Outcome Measure Information:

Title

temperature

Description

change from baseline superficial temperature of the gluteous skin at after 10 sessions

Time Frame

through study completion, an average of 1 year.

Title

score quality of life

Description

change from baseline quality of life impact in patients with cellulits at after 10 sessions

Time Frame

through study completion, an average of 1 year.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodrigo A Andraus

Organizational Affiliation

Universidade Norte do Paraná

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rodrigo Antonio Carvalho Andraus

City

Londrina

State/Province

Paraná

ZIP/Postal Code

86.041-140

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19220646

Citation

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.

Results Reference

result

PubMed Identifier

24010809

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 Sep 7.

Results Reference

result

Learn more about this trial

The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

We'll reach out to this number within 24 hrs