Comparisson of the effectiveness of fractional co2 laser and ascorbic acid with microneedling and ascorbic acid in the treatment of striae
Design
Photography, ultrasound, and skin sampling are done before the start of the treatment, then the research plan is explained to the patients, and according to the entry and exit factors, eligible patients are entered into the study. For each patient, randomly on one side Microneedling and ascorbic acid will be performed on the body and on the opposite side of CO2 laser and ascorbic acid.
Settings and conduct
The present study includes 25 patients with striae who will visit the skin clinic of Imam Khomeini Hospital in Ahvaz. Informed consent for the treatment will be obtained before the start of the treatment and will be approved by the Dermatological Research Ethics Committee.
Participants/Inclusion and exclusion criteria
Entry criteria:1. Healthy people over 18 years old and with at least one striea on the right side of the body and one striae on the left side of the body2. Absence of skin or systemic diseases interfering with wound healing or risk of keloid formation/Exit criteria:1. Any treatment method for striae in the 6 months before the study 2. History of keloid or hypertrophic scar.3. Pregnancy and breastfeeding4. Coagulation disorders5. Liver problems6. Connective tissue disease such as Ehlers Danlos7. Tissue infection at the site of the procedure8. Systemic use of retinoid within 6 months from the start of the study and/or use of immunosuppressive drugs.
Intervention groups
Group A: Co2 laser and ascorbic acid on the right side and microneedling and ascorbic acid on the left side of the body
Group B: microneedling and ascorbic acid on the right side and Co2 laser and ascorbic acid on the left side of the body
Main outcome variables
The thickness of the dermis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240505061663N1
Registration date:2024-05-10, 1403/02/21
Registration timing:registered_while_recruiting
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
elmira esmizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3444 2519
Email address
esmizadeh.elmira@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-06-09, 1403/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of fractional co2 laser with ascorbic acid and microneedling with ascorbic acid in the treatment of striae
Public title
Comparison of the effectiveness of fractional co2 laser and microneedling in the treatment of striae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people over 18 years old and with at least one striae on the right side of the body and one striae on the left side of the body Absence of skin or systemic diseases interfering with wound healing or with keloid risk
Absence of skin or systemic diseases interfering with wound healing or with keloid risk
Exclusion criteria:
Any treatment method for striae in the 6 months before the study (such as local treatments, radiofrequency, dermabrasion, chemical peeling, etc.)
History of keloid or hypertrophic scar.
Pregnancy and breastfeeding
Coagulation disorders
Liver problems
Connective tissue disease such as Ehlers Danlos
Tissue infection at the procedure site
Systemic use of retinoid within 6 months from the start of the study and/or use of immunosuppressive drugs.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, coin tossing is used, so that the valve is equivalent to method A (Co2 laser and ascorbic acid on the right and microneedling and ascorbic acid on the left) and the line is equivalent to method B (microneedling on the right and Co2 laser on the left).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a one-sided blind clinical trial, so the doctor evaluating the results and the radiologist and pathologist will be unaware of the treatment method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Jondishapour University of Medical Sience
Street address
Kianpars, West Mehr Street, Block 66, Unit 3
City
اهواز
Province
Khouzestan
Postal code
6184843573
Approval date
2024-04-07, 1403/01/19
Ethics committee reference number
IR.AJUMS.REC.1403.003
Health conditions studied
1
Description of health condition studied
Striae
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
The thickness of the dermis
Timepoint
One month after each session and one and three months after the last session
Method of measurement
clinician evaluation, patient satisfaction, change of dermis thickness according to ultrasound, change of dermis thickness according to pathology
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Co2 laser and ascorbic acid on the right side and microneedling and ascorbic acid on the left side, group B: microneedling and ascorbic acid on the right side and Co2 laser and ascorbic acid on the left side
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
tara barat
Street address
Kianpars, West Mehr Street, Block 66, Unit 3
City
ahwaz
Province
Khouzestan
Postal code
6184843573
Phone
+98 937 682 2314
Email
esmizadeh.elmira@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
tara barat
Street address
No 66. west mehr ave. kianpars. ahvaz . khuzestan
City
ahvaz
Province
Khouzestan
Postal code
6155633173
Phone
+98 61 3376 4268
Email
Esmizadeh.elmira@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
tara barat
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
no 66. west mehr ave. kianpars. ahvaz. khuzestan
City
ahvaz
Province
Khouzestan
Postal code
6155633173
Phone
+98 61 3376 4268
Email
esmizadeh.elmira@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
tara barat
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
no66. west mehr ave.kianpasr. ahvaz. khuzestan
City
ahvaz
Province
Khouzestan
Postal code
6155633171
Phone
+98 61 3376 4268
Email
esmizadeh.elmira@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
tara barat
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
no66. west mehr ave.kianpasr. ahvaz. khuzestan
City
ahvaz
Province
Khouzestan
Postal code
6155633173
Phone
+98 61 3444 2519
Email
esmizadeh.elmira@gmail.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