Objectives: The effect of microcurrent in reducing the facial wrinkles in before-after comparison in elderly women.
Design: Photographs are taken under specific conditions at the start, the end and also after 1 month post treatment to be assessed and scored by three dermatologists.
Setting and conducts: The participants will washed their face with soap and water and then 10 minutes treatment would be conducted to their forehead, around eye, around mouth, nose, cheek and chin at each side separately.
Participants: Including females the refer to Yasooj dermatologists during second half of year 1389 who had no cosmetic surgery and are nor suffering from any dermatological problems. In case of any side effects, the subjects would be excluded from the study according to dermatological approval.
Interventions: The treatment protocol is to locate the anode in stationery position and move the cathode along the treatment area towards the anode and repeat this movement for 5 times. The stimulation is of microcurrent type with square pulse, frequency 70-80 Hz and intensity of 0-640 micro Amp.
Main outcome measures: The taken photographs will be assessed by dermatologists and scored according to the size, depth and number of wrinkles from 0 to 10.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009134738N1
Registration date:2011-03-01, 1389/12/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-01, 1389/12/10
Registrant information
Name
Khosro Khademi Kalantari
Name of organization / entity
Shahid Beheshti university of medical sciences, Faculty of Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1411
Email address
k_khademi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences (International Branch)
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial to evaluate the effect of Micro-Current's on Facial Wrinkles in elderly women
Public title
clinical trial to evaluate the effect of Micro-Current's on Facial Wrinkles in elderly women
Purpose
Treatment
Inclusion/Exclusion criteria
Iinclusion criteria:
no history of cosmetic surgery and other skin problems, according to the report of a dermatologist .
Exclusion criteria:
In case of any complications, the participants would excluded according to the dermatologist opinion.
Patients also need to avoid to wear any anti-wrinkle cream or treatment during the study.
Age
From 35 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of shahid Beheshti university of medical sciences (international branch)
Street address
International branch of Shahid Behesthi University of Medical Sciences, no19, tavanir street, across Hemat
City
Tehran
Postal code
Approval date
2010-09-22, 1389/06/31
Ethics committee reference number
116/1766
Health conditions studied
1
Description of health condition studied
aging facial wrinkles
ICD-10 code
R23.8
ICD-10 code description
Other and unspecified skin changes
Primary outcomes
1
Description
The depth, size and number of facial wrinkles
Timepoint
Pretreatment, Post treatment and 1month post treatment
Method of measurement
Photographs and scoring of dermatologist
Secondary outcomes
1
Description
Persistency of facial wrinkles
Timepoint
1 month post treatment
Method of measurement
Photographs and dermatologist scoring
Intervention groups
1
Description
Treatment duration: 20 minutes daily treatment, except for the holodays, Wednesdays and fridays for 30 sessions or about 1.5 months.
Treatment method:
10 minutes treatment for one side of face and 10 minutes for the other side. the treatment lacations are forehead, around eyes, around lips and nose, cheeks and chin .
Instrument: A6 made in China having the CE certificate from England and Europe.
Treatment curent: Microcurrent with square pulse, frequency of 70-80 Hz with amplitude ranged from 0 to 640 microampere.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez physiotherapy center
Full name of responsible person
Fateme saniee, Dr. Khosro Khademi, Dr. Nader Dabiri
Street address
Hafez physiotherapy center, Daneshamooz street, Bimarestan street
City
Yasooj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences (International branch), Vice Chancellor for Research
Full name of responsible person
Dr. Rahmati Roodsari
Street address
International branch of Shahid Beheshti University of Medical Sciences, Tavanir street, Across Hemat
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences (International branch), Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr khosro khademi kalantari
Position
PHD in physiotherapy
Other areas of specialty/work
Street address
Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences, Damvand ave
City
Tehran
Postal code
Phone
+98 21 7756 1411
Fax
+98 21 7756 1406
Email
K_khademi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasooj Welfare Organisation
Full name of responsible person
Fateme Saniee PT
Position
PT MSc student
Other areas of specialty/work
Street address
Hafez Physiotherapy
City
Yasooj
Postal code
Phone
+98 74 1223 4850
Fax
Email
nooshin49@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasooj Welfare Organization
Full name of responsible person
Fateme Saniee
Position
PT MSc student
Other areas of specialty/work
Street address
Hafez Physiotherapy, Bimarestan street, Danesh amooz street
City
Yassoj
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)