Objectives:Comparison effect of nokor and blunt subcision blade in treatment of acne scars. Design: Randomized, single blind, clinical trial.
Setting and Conduct:In this study 28 patients were selected for acne scar treatment and primary data were collected and then one side of the face of eligible patients received subcision with nokor and the other side received subcision with blunt subcision blade randomly. Outcome measures will be assessed by the use of serial photography at baseline, two, and six months after the subcision therapy session by two independent dermatologists blinded to the randomization. Major Inclusion and Exclusion criteria: Inclusion criteria: patient suffering from polymorphic and mixed acne scars without presence of hypertrophic or Keloid scars;the acne scars were in both sides of the face; informed consent for participation;Most of the patient acne scars were not rolling and icepick type
Exclusion Criteria: patient discontinuing intervention;doing parallel treatments by the patient; patient not returning for follow up visits
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030526905N1
Registration date:2016-04-20, 1395/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-20, 1395/02/01
Registrant information
Name
Alireza Asemi Esfahani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9096
Email address
a_asemi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of nokor and blunt subcision blade in treatment of acne scars
Public title
Comparison effect of two surgical method in treatment of acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient suffering from polymorphic and mixed acne scars without presence of hypertrophic or Keloid scars;the acne scars were in both sides of the face; informed consent for participation.patients suffering from acne scars and most of the scars were not rolling and icepick type
Exclusion Criteria: patient discontinuing intervention;doing parallel treatments by the patient; patient not returning for follow up visits
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2016-02-07, 1394/11/18
Ethics committee reference number
IR.MUI.REC.1394.3.828
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
Atrophic scar of acne
Timepoint
two and six month after the subcision
Method of measurement
by two independent dermatologists blinded to the randomization
Secondary outcomes
1
Description
surgical complications
Timepoint
After three days, one week, two month and six months after subcision therapy
Method of measurement
Patient self administered checklist of overall satisfaction
2
Description
Clinical improvement of atrophic scar
Timepoint
Two and six months after treatment
Method of measurement
serial photography and evaluation by two independent dermatologists blinded to the randomization
3
Description
Patients satisfaction
Timepoint
2 and 4 and 8 weeks after the treatment
Method of measurement
Patient self administered checklist of overall satisfaction
Intervention groups
1
Description
(control group) On the other side of the face,subcision with nokor is done.
Category
Treatment - Surgery
2
Description
In one side of the face,subcision with blunt subcision blade is done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra general hospital
Full name of responsible person
Dr.Alireza Asemi Esfahani
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences,Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Skin disease and Leishmaniasis Research Center
Full name of responsible person
Dr.Alireza Asemi Esfahani
Street address
Skin disease and Leishmaniasis Research Center, KHorram street, Isfahan
City
Isfahan
3
Recruitment center
Name of recruitment center
Spadana clinic
Full name of responsible person
Dr.Alireza Asemi Esfahani
Street address
Daghighi street,Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Nematbakhsh
Street address
Deputy of Research of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
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 of Isfahan 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
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences,
Full name of responsible person
Dr.Alireza Asemi esfahani
Position
Assistant of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan
Postal code
Phone
+98 318173955765
Fax
Email
a_asemi@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Gita Fagihi
Position
professor
Other areas of specialty/work
Street address
Department of Dermatology, Al Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences .
City
Isfahan
Postal code
Phone
+98 31 3663 3061
Fax
+98 31 3663 3061
Email
g_fagihi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences,
Full name of responsible person
Dr.Alireza Asemi Esfahani
Position
Assistant of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8173955765
Phone
+98 31 3628 9194
Fax
Email
a_asemi@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)