Efficacy and side effects of Er:YAG laser in combination with Nd:YAG laser in the treatment of acne scars and comparing it with Er:YAG laser alone in the treatment of atrophic acne scars
Proposing a newer and more effective treatment method in the treatment of atrophic acne scars
Design
In this study, 20 patients with atrophic acne scars on both sides of the face were included in the study
One side of the patient's face is treated with Er:yag laser alone and the other side is treated with a combination of Er:yag and Nd:yag lasers.
Settings and conduct
This study is conducted in Razi Hospital laser clinic between 2022 and 2024.
In this study, 20 patients with atrophic acne scars on both sides of the face were included in the study
One side of the patient's face is treated with Er:yag laser alone and the other side is treated with a combination of Er:yag and Nd:yag lasers.
All patients and dermatologists evaluating the result are unaware of the type of laser received on both sides of the face.
The results of recovery and complications are evaluated by Visioface and the ECCA criteria and the satisfaction percentage of the patients themselves
Participants/Inclusion and exclusion criteria
Inclution criteria: patients over 18 years old with mild to moderate scarotrophic acne on both sides of the face
Exclution criteria: pregnancy, history of isotretinoin use and performing invasive procedures such as subcision, dermabrasion, peeling, and laser on the cheeks in one month the past
Intervention groups
One side of the patient's face is treated with Er:yag laser alone and the other side is treated with a combination of Er:yag and Nd:yag lasers, and the effects of both are compared.
Main outcome variables
Depth and size and number of acne scars in laser therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221031056355N1
Registration date:2022-12-07, 1401/09/16
Registration timing:registered_while_recruiting
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
sareh zanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 349 8079
Email address
sarazanjani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-04, 1401/08/13
Expected recruitment end date
2023-11-04, 1402/08/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and side effects of Er:YAG laser in combination with Nd:YAG laser in the treatment of acne scars and comparing it with Er:YAG laser alone in the treatment of atrophic acne scars
Public title
Effect of laser in treatment of acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with mild to moderate acne atrophic scars on both sides of the face
Exclusion criteria:
A history of performing invasive procedures on the skin in the last month
pregnancy
history of keloid
lactation
Presence of active acne
photosensitivity
History of taking Rovacutan in the last month
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the face is treated with Er:yag laser and the other side is treated with a combination of Er:yag and Nd:yag lasers
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients and the dermatologist evaluating the outcome are unaware of which type of laser was used on which side of the face
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University Medical School Community Verified icon
Street address
vahdateslami street .razi hospital
City
tehran
Province
Tehran
Postal code
1199663911
Approval date
2022-10-21, 1401/07/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.546
Health conditions studied
1
Description of health condition studied
Acne scar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of acne scars based on The ECCA grading scale (échelle d’évaluation clinique des cicatrices d’acné)
Timepoint
Examining the severity of acne scars based on the criteria determined before the start of the intervention and after the fourth laser session (4 sessions with an interval of one month)
Method of measurement
Based on the famous ECCA acne severity scoring table
2
Description
Visioface images to determine the number of skin pores
Timepoint
Examining the severity of acne scars based on the criteria determined before the start of the intervention and after the fourth laser session (4 sessions with an interval of one month)
Method of measurement
visioface device
Secondary outcomes
1
Description
Investigation of laser side effects such as erythema
Timepoint
After each laser session (4 sessions with an interval of one month)
Method of measurement
Visual observation
Intervention groups
1
Description
Intervention group: on one side of the face of patients with etheroic acne scars, Er:yag laser with the number of 4 sessions at an interval of one month and checking the results one month after the fourth session.
Category
Treatment - Other
2
Description
The intervention group: On the other hand, the study group received Er:yag and Nd:yag lasers for four sessions with an interval of one month, and the results were checked one month after the last session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital Laser Clinic
Full name of responsible person
sareh zanjani
Street address
vahdat eslami street razi hospital
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 915 349 8079
Email
sarazanjani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
.Vice President of University Research and Technology
Street address
vahdateslamistreet,razi hospital
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 915 349 8079
Email
sarazanjani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
sareh zanjani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
vahdateslami street.razi hospital
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 915 349 8079
Email
sarazanjani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sareh zanjani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
vahdateslami street.razi hospital
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 915 349 8079
Email
sarazanjani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sareh zanjani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
vahdateslami street.razi hospital
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 915 349 8079
Email
sarazanjani@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