Determine the efficacy and safety of subcision with barikbins-blunt-subcision-blade type C in comparison with Needle No. 22 in the treatment of atrophic acne scars
Design
In this study, 32 patients with atrophic acne scars in both sides of their face referred to Shahdai Hospital during the period of 1395 to 1396 were evaluated for inclusion criteria and exclusion criteria.The two sides of the face are randomly divided into two groups A and B, and analysts and patients are not aware of the type of group and only the surgeon is aware of the study group.
Settings and conduct
This randomized clinical trial was conducted in patients with atrophic acne scars in two parts of their face who referred to laser clinic of Shohadaye Tajrish Hospital. The two sides of the patients were randomly divided into two groups, and analysts and patients are unaware of the type of group and only the surgeon is aware of the study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria : age 18 to 50 years; complete patient satisfaction; participation in atrophic acne scars on both sides of the species with relatively similar severity on both sides; Exclusion criteria: active nodulosistic acne (more than 6 papules or nodule on each side of the face); active skin infection (for example, herpes simplex or jaundice infection); hematological disorders or coagulopathy; Immunosuppression; dermatological diseases interact with the procedure; previous history of colloid; use of medications that prolong the bleeding time (especially aspirin, warfarin or vitamin E); isotretinoin in the last 12 months; resurfacing in 6 Last month included dermabrasion, laser therapy, chemical peeling; pregnancy or breastfeeding;
Intervention groups
Face A side: Under subcision with BBSB type C.
Face B side: Perform subcision with the needle number 22.
Main outcome variables
Severity of atrophic scars
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N29
Registration date:2018-01-21, 1396/11/01
Registration timing:retrospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
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
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2015-03-21, 1394/01/01
Actual recruitment end date
2016-03-20, 1395/01/01
Trial completion date
empty
Scientific title
Evaluation of Efficacy of BBSB type C in comparison with needle subcision on atrophic acne scar
Public title
The effect of subcision on acne scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years old
Patient's complete consent to participate in the study
Acne atrophic scars on both sides of the species with a relatively uniform intensity on both sides
Exclusion criteria:
Active nodulosistic acne (more than 6 papules or nodules on each side of the face)
Active skin infection ( herpes simplex or jaundice infection)
Hematological disorders or coagulopathy
Immunosuppression
Dermatological diseases interfere with the procedure
Previous biography of colloids
Taking medications that prolong the bleeding time (especially aspirin, warfarin or vitamin E)
Isotretinoin intake over the past 12 months
Performing resurfacing procedures over the past 6 months include dermabrasion, laser therapy, chemical peeling
Pregnancy or breastfeeding
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the face treated with subcision and the other side treated with needle.
Actual sample size reached:
32
More than 1 sample in each individual
Actual sample size in each individual:
2
One side of the face treated with subcision and the other side treated with needle.
Randomization (investigator's opinion)
Randomized
Randomization description
The patient's face are divided into two intervention groups 1 and 2 according to a simple randomized 1: 1 random number table. The analyst and the patient are not aware of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The group and side of the face are placed in pairs and in dark envelopes. It is available to the surgeon and only the surgeon is informed of the patient's healing side. Procedures in this project are done by a skilled dermatologist. The envelope will be opened by a physician only after initial evaluations in each person, and neither patients nor analysts will be aware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.927
Health conditions studied
1
Description of health condition studied
Atrophic acne scar
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Primary outcomes
1
Description
Severity of atrophic scars
Timepoint
Before starting treatment, in the first week after treatment, the first month, the third month and the sixth month after treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:The A side is required to be subcision to BBSB type C. The site of the entry of the subcision blade is at a point in the 1 cm front and 2 cm ahead of the ear tragus. Iodine is used to sterilize the area. Tomsent solution is combined with 50 cc of lidocaine, 1% pure, 1 cc epinephrine, 0.1% and 10 cc of sodium bicarbonate solution, 4.2% in normal saline 1 liter for local anesthetic. 50 to 100 cc of this solution is injected in a sub-dermal plaque with gauge 23 needle at 4 to 7 dots. For subcision, BBSB type C is used. Through the inlet area that has already been identified and numb, the blade number C is entered on the parallel plan with the skin on the subdermal plate and the smooth surface of the blade is facing up (the index of the thumb is on the handle to indicate it ) All fibrous bands are released by moving forward and backward, and by moving the pseudo-fan, the blade is moved to the adjacent portions. The blade is moved slowly to avoid excessive force and damage to the nerves and vessels and to the skin. Also, the lack of movement of the blade to the lateral will also help prevent this damage. About two-thirds of the length of the blade can be entered into the skin and used from an entrance area for the entire scar area of the face side. After the procedure, an antibiotic with an without pressure gas for simple dressing is used. Oral antibiotics or anti-viral antibiotics are prescribed according to individual needs. Patients are educated about the possibility of edema, bruising, mild thrombosis in the first few days. Patients are advised to sleep semi sitting for two nights to reduce swelling.
Category
Treatment - Devices
2
Description
Intervention group2: On the B side, perform the subcision with the needle number 22. After determining the range and location of atrophic scars with non-toxic surgical markers, the range is averaged by about 10 cc of lidocaine-2% pure without epinephrine. For subcision, 22-gauge needles are used for deep-scarves and 27-gauge scarves for surface scars attached to a 1-cc syringe. The skin of the patient is pinched or stretched by a non surreptitious surgeon to make the skin firm and non-moving. By inserting the needle from the proximal axial atrophic scar, the fibrous bands are released by forward movement and lateral movement in parallel planes of the skin and in the scars area and about 1 mm from the margin. For each atrophic scar, at least one entry point and sometimes a needle insertion area are required. The ultimate goal is to move the needle from the horizontal to the lateral, along with a mild hematoma in the atrophic scar region and a swelling in the surface of the scar. Hemostasis is done by placing a non-pressure gas in the area. The maximum number of atrophic scars in the patient's range will be treated on that side. After the procedure, an antibiotic with an without pressure gas for simple dressing is used. Oral antibiotics or anti-viral antibiotics are prescribed according to individual needs. Patients are educated about the possibility of edema, bruising, mild thrombosis in the first few days. Patients are advised to sleep semi sitting for two nights to reduce swelling.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Dr Behrouz Barikbin
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Behrouz Barikbin
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Behrouz Barikbin
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Behrouz Barikbin
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available