Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000255088
Ethics application status
Approved
Date submitted
15/03/2010
Date registered
25/03/2010
Date last updated
25/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrotherapy in localized fat
Scientific title
Effects of polarised current and iontophoresis application in localised fat in sedentary women.
Secondary ID [1] 1509 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
localized fat 257024 0
Condition category
Condition code
Diet and Nutrition 257111 257111 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sample was divided randomly into four groups: A, B, C and D. Each group consisted of 6 women: the group A was subject to the application by polarized current (diphasic, longa and short period and galvanic), 30 minutes each session, held twice a week for 5 weeks, the group B to iontophoresis,with teh product cetella asiatic, 30 minutes each session, held twice a week for 5 weeks the group C to the direct application under the skin of cosmetic cosmetic centella asiatic and group D, the control. The groups A and B were submitted to 10 applications by electrostimulation, 30 minutes each session, held twice a week. The group C applied the cosmetic (centella asiatic), 30 minutes, twice a week for 5 weeks and group D, the control, was not subjected to any procedure being re-evaluated after 5 weeks.
Intervention code [1] 256145 0
Treatment: Other
Comparator / control treatment
grupo D, not subjected to any procedure and re-evaluated after 5 weeks
Control group
Active

Outcomes
Primary outcome [1] 258006 0
localized fat- visual inspection
Timepoint [1] 258006 0
evaluation (before first session) and reevaluation (after last session)
Secondary outcome [1] 263562 0
body composition- adipometry (skinfold) test
Timepoint [1] 263562 0
first and last session
Secondary outcome [2] 263563 0
weigt measured of body mass (BMI)
Timepoint [2] 263563 0
first and last session
Secondary outcome [3] 263564 0
abdominal circunferemces- with tape
Timepoint [3] 263564 0
first and last section

Eligibility
Key inclusion criteria
sedentary, with fat deposition in the region of the flanks
no preagnancy
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
practice physical activity women, pregnancy, abdominal surgery and they were doing some kind of diet.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
it was selected 40 volunteers and it was treated in the tuiuti university´s ambulatory; The evaluator made a questionary with exclusions criterios. After the volunteers was divided randomly with sealed opaque envelopes in four groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomizatiom by usong a randomization table from statistics book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 2540 0
Brazil
State/province [1] 2540 0
parana

Funding & Sponsors
Funding source category [1] 256648 0
University
Name [1] 256648 0
Tuiuti do Parana
Country [1] 256648 0
Brazil
Primary sponsor type
University
Name
Tuiuti do Parana
Address
Rua Sydnei Antonio Rangel Santos, nº 238
santo inacio- curitiba- parana
CEP: 80710250
Country
Brazil
Secondary sponsor category [1] 255935 0
None
Name [1] 255935 0
Address [1] 255935 0
Country [1] 255935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258672 0
Tuiuti ethics committee and research
Ethics committee address [1] 258672 0
Rua Sydnei Antonio Rangel Santos, n 238
santo inacio- curitiba- parana CEP 80710250
Ethics committee country [1] 258672 0
Brazil
Date submitted for ethics approval [1] 258672 0
30/05/2008
Approval date [1] 258672 0
26/06/2008
Ethics approval number [1] 258672 0
0042/2008

Summary
Brief summary
In the dermato-functional therapy area, the iontophoresis with specific cosmetic is used as an adjunct in the treatment of localized fat, lipodystrophy gynoid, hypertrophic scars and keloids. Due to the lack of literature on treatments for localized fat, the purpose of this study was to compare the effects of the current polarization and iontophoresis in the treatment of localized fat on the flanks in sedentary women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30935 0
Address 30935 0
Country 30935 0
Phone 30935 0
Fax 30935 0
Email 30935 0
Contact person for public queries
Name 14182 0
ana carolina brandt de macedo
Address 14182 0
rua aristides pereira da cruz, 01 casa 57. curitiba - parana
CEP: 80330290
Country 14182 0
Brazil
Phone 14182 0
554133330025
Fax 14182 0
Email 14182 0
[email protected]
Contact person for scientific queries
Name 5110 0
ana carolina brandt de macedo
Address 5110 0
rua aristides pereira da cruz, 01 casa 57. curitiba - parana
cep 80330290
Country 5110 0
Brazil
Phone 5110 0
554133330025
Fax 5110 0
Email 5110 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEfeitos da aplicação da corrente polarizada e da iontoforese na gordura localizada em mulheres2013https://doi.org/10.1590/s0103-51502013000300020
N.B. These documents automatically identified may not have been verified by the study sponsor.