Comparision of Effeectiveness of Fractional Co2 Laser and Erbium Yag Laser in Treatment of Acne Scar in Patient Referred to Educational Clinical of Isfahan Univercity of Medical Sciences
Comparison of Fractional CO2laser and Erbium yag laser in treatment of acne scar
Design
Clinical trial with two intervention group, two parallel group ,double-blind, randomized on 30 patients.Excel software rand function was used for randomization.
Settings and conduct
The study is performed in Al-Zahra Hospital in Isfahan in such a way that patients who meet the inclusion criteria enter the study. On the one side of their face erbium laser is used , and on the other side CO2 laser is applied.
Participants/Inclusion and exclusion criteria
Having an acne scar on both sides of the face is a prerequisite for entry, and having a history of keloids and having a history of using isotretinoin in the last 6 months and having a history of injections in the last 6 months are prerequisite for exit.
Intervention groups
CO2 laser and Erbium laser and their effects on improving acne scar
Main outcome variables
Improving acne scar, redness, and hyperpigmentation on face
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210217050399N1
Registration date:2021-08-25, 1400/06/03
Registration timing:registered_while_recruiting
Last update:2021-08-25, 1400/06/03
Update count:0
Registration date
2021-08-25, 1400/06/03
Registrant information
Name
Zahra Safavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6240
Email address
maryam.safavi@uni-bonn.de
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
2021-08-01, 1400/05/10
Actual recruitment end date
2021-11-01, 1400/08/10
Trial completion date
2021-11-01, 1400/08/10
Scientific title
Comparision of Effeectiveness of Fractional Co2 Laser and Erbium Yag Laser in Treatment of Acne Scar in Patient Referred to Educational Clinical of Isfahan Univercity of Medical Sciences
Public title
laser in treatment of acne scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of acne scar on both sides of the face
Exclusion criteria:
Past history of keloid
Using isotretinoin in the last 6 months
Injection of filer in the last 6 months
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and the doctor who compares and scores both sides of the face are kept blind. Study participants do not know what kind of laser is done on each side of their face.Also, the doctor who has to score the improvement of each side does not know what kind of laser has been done on each side of the patients face.
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
No.58,Mosadegh-zadeh Alley, Jey street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
٨١٥٦٩١٣٤٥٣
Approval date
2019-04-14, 1398/01/25
Ethics committee reference number
IR.MUI.MED.REC.1397.294
Health conditions studied
1
Description of health condition studied
Acne scar
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
Aacne scar according to VAS SCORE
Timepoint
Before and one month after laser therapy
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :The CO2laser is performed on one side of the face by a CO2laser device once a month for 3 months.
Category
Treatment - Other
2
Description
Intervention group :The Erbium YAG laser is performed on one side of the face by a Erbium YAG laser device once a month for 3 months.
Category
Treatment - Other
3
Description
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Zahra Safavi
Street address
No.58,Mosadegh-zadeh Alley,Jey street,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8156913453
Phone
+98 31 3522 6240
Email
maryam.safavi@uni-bonn.de
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
No.58,Mosadegh-zadeh Alley,Jey street,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8156913453
Phone
+98 31 3522 6240
Email
maryam.safavi@uni-bonn.de
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Safavi
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.58,Mosadegh-zadeh Alley,Jey street,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8156913453
Phone
+98 31 3522 6240
Email
maryam.safavi@uni-bonn.de
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Safavi
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.58,Mosadegh-zadeh Alley,Jey street,isfahan
City
Esfahan
Province
Isfehan
Postal code
8156913453
Phone
+98 31 3522 6240
Email
maryam.safavi@uni-bonn.de
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Safavi
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
815
Phone
+98 31 3522 6240
Email
maryam.safavi@uni-bonn.de
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