Protocol summary

Summary
With the aim of determining the efficacy and side effects of sub-cirrhosis by Blunt Subcision Blade in the treatment of nasolabial China, 10 volunteers with deep nasolabial fibrils, after obtaining enough information and obtaining written and informed consent, are willing to enter the study. They are studying with China's criteria for the deep-seated double-sided nasolabial syndrome of over 18 years of age. Patient with raccoon over the past 12 months, the presence of active skin infection in the face, lidocaine susceptibility, breastfeeding and pregnancy, the history of inherited or acquired connective tissue diseases, the use of any topical preparations on the face except sunscreen in Last three months, performing beautiful beauty treatments such as laser and photodynamic therapy in a past year, filler injections or fat in the last five years are excluded from the study process. First, the target area is marked on both sides of the patient's face and underneath Subcutaneous local sensory involvement with lidocaine 1% with epinephrine 1: 100,000. The sub system is conducted in this study by the DR BB Subsicion Device, which is a blind spindle and is specially designed to have a proximal section of the circular shape and gradually to the distal end and allow the path to move It has a tissue. The device is applied to the skin from the nosebleed nosebleed in the horizontal position to the lip of the lips and about two centimeters long. This treatment is repeated for 2 sessions with a 2-week interval. To be Patients will be examined before treatment and 1 month after the end of treatment. The results will be evaluated quantitatively and qualitatively. In a qualitative way, standard patient photography is performed with the VisioFace device and the patient will be asked about possible side effects. Photos are compared by two independent dermatologists. Ultimately, the rate of improvement is estimated as no response (recovery less than 10%) of low response (recovery between 25- 10%) moderate response (recovery between 25-75%) and excellent response (recovery rate greater than 75%) In addition, in order to determine the severity of wrinkles, dermatologists use the Wrinkle Severity Rating Scale (WSRS) system, which heavily scores between 0 and 5 scores.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201705278146N19
Registration date: 2017-08-14, 1396/05/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of efficacy and adverse effects of subsicion with blunt subcision blade in the correction of nasolabial fold depth
Public title
The evaluation of subsicion in the correction of nasolabial fold depth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diphtheria nasolabial hyperlipidemia, over 18 years old;Exclusion criteria: Dissatisfaction or willingness to continue the study for any reason; Use of racotene over the past 12 months; Presence of active skin infection in case; Lidocaine susceptibility; Lactation; And pregnancy; the history of inherited or acquired diseases of the connective tissue; the use of any topical preparations other than sunscreen during the last three months; performing beautiful facial procedures like lasers and photodynamic therapy in one year; injection of filler or Fat in the last 5 years;
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
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
Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Blvar.Velenjak
City
Tehran
Postal code
Approval date
2016-12-18, 1395/09/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.928

Health conditions studied

1

Description of health condition studied
Nasolabial fold
ICD-10 code
L90.8
ICD-10 code description
Other atrophic disorders of skin

Primary outcomes

1

Description
The severity of nasolabial wrinkles
Timepoint
Before treatment,One month after the end of treatment
Method of measurement
biometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Subsicion was performed in this study by a sub system. The device was inserted into the skin from the hole in the nasolabial nose in the hole created by the needle number 18, which is horizontal in the horizontal direction to the lip and at a distance of about two centimeters. This treatment can be repeated for 2 sessions at intervals of 2 weeks.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
laser application in medical sciences research center
Full name of responsible person
Dr.Behrouz Barikbin
Street address
Shohadaye Tajrish Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Daneshkoo Blvd.Velenjak
City
Tehran
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
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
Laser Application research center in medical science
Full name of responsible person
Dr.Behrooz Barikbin
Position
dermatologist
Other areas of specialty/work
Street address
Shohada Hospital-Tajrish
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
bbarikbin@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Laser Application research centre in medical sciences
Full name of responsible person
Dr.Behrooz Barikbin
Position
dermatologist
Other areas of specialty/work
Street address
Shohada Hospital-Tajrish
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
bbarikbin@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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