Comparison of the efficacy and effectiveness of the subcision by cannula as a new therapeutic approach with the common method of subcision with needle
Design
The present study was designed to evaluate the efficacy and safety of using subsicion with cannula and minimizing its side effects for patients. Patients with inclusion criteria are assigned to 2 subgroups of subsicion therapy by cannula and sub-cognitive therapy group Needle, and the sample size is estimated at 50 for each group.
Settings and conduct
Before submission, photography will be done in 3 angles, Straight forward, Right side view and left side view by digital camera with high resolution and vicious face device for scar or ulcer region in patients face, and all patients will be photographed before and after treatment and results will be analyzed by independent dermatologist at the skin and stem cell research center .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60; Developing middle to severe rolling scar in face region. Exclusion criteria: Age less than 20 years; Pregnancy and breastfeeding; Coagulation disorder background, or using drugs related to coagulation; Active infection in face; Unwillingness or disability in following up in defined periods of time; Background of heredity and adventitious connective tissue diseases; Skin cancer in face; Using any local drugs on face except sun protection creams in last month; Doing beauty procedures on face such as laser or photodynamic therapies in last year.
Intervention groups
First intervention group: subsicion with cannula method.
Second intervention group: subsicion with needle method.
Main outcome variables
scar's surface; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001159N22
Registration date:2019-04-18, 1398/01/29
Registration timing:retrospective
Last update:2019-04-18, 1398/01/29
Update count:0
Registration date
2019-04-18, 1398/01/29
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin and Stem cell Research Center of Tehran University of Medical Sciences and Jordan Dermatology and Hair Transplantation Center
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between method of subcision by cannula as a new therapeutic way and common subcision by needle method in the treatment of acne scars
Public title
Comparison of the new method of subcision by cannula with common needle method in the treatment of scars.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having middle to severe rolling scar in face region
Age between 20-60
Exclusion criteria:
Pregnancy and breastfeeding
Coagulation disorder background
Active infection in face
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2014-02-23, 1392/12/04
Ethics committee reference number
92-03-150-24394-105805
Health conditions studied
1
Description of health condition studied
Scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
surface scars
Timepoint
Before each surgery
Method of measurement
visioface
2
Description
side effects
Timepoint
One week after surgery
Method of measurement
Questionnaire and visit
3
Description
Patient Satisfaction
Timepoint
One month after each surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Subsicion group with cannula: two sides of the face of patient will be gotten surgery by three 4 weeks interval sessions with cannulas number 18 and 21
Category
Treatment - Surgery
2
Description
Subsicion group with needle: : two sides of the face of patient will be gotten surgery by three 4 weeks interval sessions with needle number 18G
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Elahe Lotfi
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iranئدد0
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
tmarkaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2251 5558
Email
tmarkaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Elahe Lotfi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
193757511
Phone
+98 21 2223 9387
Fax
Email
el_le_18@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2223 9387
Fax
Email
nilforoosh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical sciences
Full name of responsible person
Mona Mahmoudbeyk
Position
Research manager
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
mmahmoodbeyk@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available