The patients who are suffering from Atrophic Rolling Acne Scars are studied according inclusion criteria and after first examination and preforming reviscometry the tumescent solution (including 1cc of epinephrine, 1000 N/S cc, 10 cc of bicarbonate and 50cc of lidocaine) is injected and after 15 minutes the subcision is performed on half of the face randomly by the cannula blunt method and the subcision on the other half of the face is performed by Nokor needle. After all done the entry parts of Nokor needle and cannula on skin are sutured and get bandaged with gentamicin eye cream. Patients are advised to follow up after one week, one month and 3 months after procedure for assessment of skin lesions. The assessment of patient is held with visiting, first with one week then one month and finally 3 months after procedure. In each of these visiting the photo of patients is taken and based on healing of skin lesions and satisfaction of the patients the score is given, in this way that the score 0 for poor improvement, the score 3 for mediocre improvement, for good improvement score 6 and for complete improvement score 9 is considered. Also patients under reviscometry are evaluated for degree of elasticity which elastic is one of the index that is considered. Plus in each follow up session some side effects such as bleeding, Hematoma, nervous cycle and possibility of infection are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082927707N2
Registration date:2017-09-27, 1396/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Behzad Iranmanesh
Name of organization / entity
Shahid Behshti Medical University,Skin Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2676 1435
Email address
mgheisari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Shahid Beheshti University of Medical Science
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of subcision using blunt canula and nokor needle as split-face method in patients with atrophic acne scar
Public title
Comparison of efficacy of subcision using blunt canula and nokor
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients with atrophic acne scar (rolling type); the range of age betwwen 18 to 65
exclusion criteria: pregnancy; autoimmune connective tissue disorder; cronary artery disease; coagulopathy; local infection; history of hayper trophic scar; inflamtory cutaneous disorders (psoriasis,lichen planus)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shahid Beheshti University of Medical Science
Street address
Shahid Beheshti University of Medical Science, Next to Ayatollah Taleghani Hospital, Evin,Tehran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SBMU.SRC.REC.1395.28
Health conditions studied
1
Description of health condition studied
Acne scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Acne scar
Timepoint
Before intervention, 1 and 3 month after intervention
Method of measurement
Objective
Secondary outcomes
1
Description
Edema
Timepoint
1 and 3 month after intervention
Method of measurement
Observation
2
Description
Echymose
Timepoint
1 and 3 month after intervention
Method of measurement
Observation
3
Description
Nodule
Timepoint
1 and 3 month after intervention
Method of measurement
Observation
Intervention groups
1
Description
First group: acne scars were treated with blunt canula.
Category
Treatment - Surgery
2
Description
Second group: acne scars were treated with Nokor needle.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Bita Saghi
Street address
Shohada Hospital, Tajrish square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor in research Affairs of Shahid Beheshti University of Medical Science
Full name of responsible person
Dr.Afshin Zarghi
Street address
Shahid Beheshti University of Medical Science, Next to Ayatollah Taleghani Hospital, Evin, Tehran
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 in research Affairs of Shahid Beheshti University of Medical Science
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
Skin Research Center
Full name of responsible person
Bita Saghi
Position
Dermatology Resident
Other areas of specialty/work
Street address
Skin Research Center, Shohada Hospital, Tajrish square, Tehran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
dr.saghi2020@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Dr. Mehdi Gheisari
Position
Dermatologist
Other areas of specialty/work
Street address
Skin Research Center, Shohada Hospital, Tajrish square, Tehran
City
Tehran
Postal code
Phone
+212 2741507
Fax
Email
Mgheisari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Bita Saghi
Position
Dermatology resident
Other areas of specialty/work
Street address
Skin Research Center, Shohada Hospital, Tajrish square, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
dr.saghi2020@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)