Determining the effectiveness of microneedling in comparison with topical retinoids in the treatment and improvement of acne scars in patients referred to acne scars based on ECCA scale
Determining the effectiveness of microneedling in comparison with topical retinoids in the treatment and improvement of acne scars in patients referred to acne scars based on VAS scale
Design
A clinical trial with a control group and a parallel one-way blind phase intervention group will be performed on 80 patients.
Settings and conduct
This study is performed in the dermatology clinic of Sabzevar Vasei Hospital
Participants/Inclusion and exclusion criteria
All patients with acne scars who did not attend the study were referred to a dermatology clinic
Patients who have used systemic retinoic or immunosuppressive drugs for the past 3 months, patients with coagulation insufficiency or bleeding disorders, patients with evidence of colloidal scarring and active acne lesions, and pregnant and lactating women are not included in the study. To be
Intervention groups
The intervention group will undergo microneedling. And the control group will use topical retinoid cream every other dayک
Main outcome variables
Sunken acne scars
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210312050680N1
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Mohammad Tajik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3258 4319
Email address
dr.moh.tajik@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-31, 1400/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Microneedling Effect with Topical Tretinoin in Treatment of Acne Scars in dermatology clinic
Public title
Effect of Tretinoin in treatment of Acnea with Microneeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Acnea Scars in dermatology Clinic
Exclusion criteria:
Pregnant women.
People taking immunosuppressive drugs.
People with coagulation failure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used for randomization. The randomization unit is individual.
The allocation of samples in the study was based on random sequence of statistical software (Random allocation software). The sequence used was in the form of four blocks.
To hide from the method of opaque envelopes stamped and
The wax was applied in a random sequence
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients divided in 2 groups one of them is control and another group is intervention.
A checklist is assigned to each patient
After completing the data plan, it is delivered to the statistical consultant who has been blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Asad abadi
City
Sabzevar
Province
Razavi Khorasan
Postal code
1234567890
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.MEDSAB.REC.1399.189
Health conditions studied
1
Description of health condition studied
acnea
ICD-10 code
L90.8
ICD-10 code description
Other atrophic disorders of skin
Primary outcomes
1
Description
People with atrophic acne scars who have a theoretical analog scoring system with a score of at least 3
Timepoint
Will be checked in weeks 6, 12 and 18
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: after determining the severity of atrophic scars, a dermatologist will undergo microneedling. First, a local anesthetic is injected and given a 30-minute opportunity, in which the Mars device will be used at a speed of 2800 Up to 3200 depending on the location of the scars, the duration of microneedling will vary. In the intervention group, microneedling will be performed in three stages. At 6,12,18 weeks, the amount of improvement is first scored and changes are recorded with a camera
Category
Treatment - Devices
2
Description
Control group: In this group, as in the patient intervention group, a dermatologist visits and the severity of the acne scar is determined based on analogous scoring. 2800 to 3200 and depending on the location of the lesions, the time varies, then they come back 6, 12, 18 weeks later, during this period, they use topical retinoid cream every other night.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Maryam Karrabi
Street address
Shohada Hastei st
City
Sabzevar
Province
Razavi Khorasan
Postal code
1234567890
Phone
+98 51 4477 8932
Email
info@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam Karabi
Street address
Asad Abadi
City
Sabzevar
Province
Razavi Khorasan
Postal code
1234567890
Phone
+98 51 4423 7689
Email
info@medsab.ac.ir
Web page address
http://www.medsab.ac.ir/index
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Tajik
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahar St. Medical Dormitory
City
Sabzevar
Province
Razavi Khorasan
Postal code
1234567890
Phone
+98 51 4487 6532
Email
dr.moh.tajik@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam karabi
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 80 .Asad Abadi st
City
Sabzevar
Province
Razavi Khorasan
Postal code
1234567890
Phone
+98 51 4490 8064
Email
maricori@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Tajik
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bahar st Medical Sciences Dormitory
City
Sabzevar
Province
Razavi Khorasan
Postal code
12323567890
Phone
0985144890965
Email
dr.moh.tajik@gmail.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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only part of the data related to the main outcome can be shared
When the data will become available and for how long
Start of access period 1 year after printing
To whom data/document is available
Only available to academic researchers
Under which criteria data/document could be used
Dermatologists
From where data/document is obtainable
Mr. Mohammad Tajik
Address Sabzevar, Bahar St., dormitory of medical sciences
What processes are involved for a request to access data/document