1. To evaluate the effect of high power laser (2W) and dry needling on epidermis and dermis thickness
2. To Assess the effect of High Power Laser (2W) and Dry Needling on Nasolabial fold area, depth, and elasticity
3. To determine the usage of High Power Laser (2W) and Dry Needling on patinet’s social function
Design
In this research, 25 women between 35-55 with Modified Fizpatrick Wrinkle Scale between 2-2.5 mm, were selected and randomly divided to three groups of Laser, dry needling, and control. Group allocation was concealed by sealed numbered envelops.
Settings and conduct
This study was conducted in Tarbiat Modares University. Subject randomizedly assigned to three groups. Ultrasonography was performed first session, and after the end of the three weeks of the intervention.
Participants/Inclusion and exclusion criteria
1- Women 35-55 years of age
2- BMI 25-30
3- Nasolabial Fold depth between 2 to 2.5 mm according to Modified Fizpatrick Wrinkle Scale
4- Skin color type III and IV according to Fizpatrick Classificatin Scale
5- No treatment for Nasolabial Fold at 6 month prior to the procedure
6- Not having any kinds of skin and inflammatory diseases, diabetes, HIV, and skin scars
Intervention groups
1- High Power Laser (2w) for Nasolbial Fold and associated muscles for seven sessions.
2- Dry needling for Nasolabial Fold and assossiated muscles for seven sessions.
3- Control group receives no treatment.
Main outcome variables
Laser dosage
Nasolabial Fold depth
Nasolabial Fold area
Strain
Elasticity
Life Quality Quastionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170818035759N2
Registration date:2018-02-08, 1396/11/19
Registration timing:retrospective
Last update:2018-02-08, 1396/11/19
Update count:0
Registration date
2018-02-08, 1396/11/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 82882013
Email address
parinaz.omidi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-01-06, 1396/10/16
Trial completion date
empty
Scientific title
Evaluation and comparison of the Effect of High Power Laser (2W) and Dry Needling on skin elasticity due to aging process in aged women
Public title
Effect of High Power Laser (2W) and Dry Needling on skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women ages between 35-55
BMI between 25-30
Nasolabial Fold class between 2-2.5 according (Modified Fizpatrick Wrinkle Scale)
No other treatment for Nasolabial Fold (like Botox, Microneedling and cosmetic surgery) for 6 month before this srudy
Exclusion criteria:
Systematic diseases like HIV, Diabetes, connective tissue diseases like Lupus, Scleroderma, Sarcoidosis
Surgical and Non-Surgical Scars in treatment area
Infectious diseases in treatment area like (Cyst, skin Rashes, Herpes)
Pregnanccy
Psychological disorders
Metal alerjisi
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
25
Actual sample size reached:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly assign subjects to two interventional and 1 control group
By using envelops shuffling randomization , subjects pick up one envelope and enter one of three groups by chance
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer has no information about the treatments that subjects had
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University of Medical Sciences
Street address
Jalal AleAhmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2017-06-24, 1396/04/03
Ethics committee reference number
IR.TMU.REC.1396.559
Health conditions studied
1
Description of health condition studied
Decrease Skin Tissue Elasticity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Elasticity
Timepoint
25
Method of measurement
Ultrasound 40 MHz
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: High Power Laser (2w) for Nasolabial Fold and associated muscles for seven sessions is used. Applied energy to each nasolabial fold is 75 joule.
Category
Treatment - Devices
2
Description
Intervention group: Dry needling for Nasolabial Fold and assossiated muscles for seven sessions is used.
Category
Treatment - Devices
3
Description
Control group: Control group recieves no treatment and normal skin tissue is compared to intervention groups.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University Physiotherapy Department
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data of the study includes skin tissue elasticity, dermlal and epidermal thickness and quality of life changes. The data of major outcome is shareable and personal information and before and after picures are not shareable.
When the data will become available and for how long
access after thesis defence
To whom data/document is available
Physicaltherapy colleages and other researchers
Under which criteria data/document could be used
For research and treatment purposes
From where data/document is obtainable
There are two ways to access the data of study
1. Parinaz Omidi with Electronic Mail parinaz.omidi@modares.ac.ir
2.Dr Roya Ravanbod with Electronic Mail rravanbod@modares.ac.ir
What processes are involved for a request to access data/document
The applicant can access the data in one week by sendig E-mail to any of top Electronic Mails.