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Effectiveness of fractional co2 laser and the use of radiofrequency devices on atrophic acne scars

Protocol summary

Study aim
Determining the effectiveness of Fractional CO2 laser and the use of radiofrequency devices on atrophic acne scars in patients visiting Tehran Azad University Hospitals during 2023
Design
A clinical trial with two control groups, with parallel, unblinded, simple randomized groups, on 24 patients, was used for randomization from the random online table.
Settings and conduct
Patients with the diagnosis of atrophic acne scars referred to the affiliated hospitals of Islamic Azad University of Tehran are included in the study.Pateints are randomly divided into two groups by the online table. Demographic and clinical information of patients, including age, sex, type of atrophic scar, skin color, etc., are collected using a questionnaire. Each person is treated in 4 sessions with three-week intervals. Patients are examined and evaluated at intervals of one , two and six months after the treatment.
Participants/Inclusion and exclusion criteria
Eligibility criteria: presence of complete patient information, consent to participate in the study, age over 18 years and under 70 years Exclusion criteria: existence of disease background, pregnancy and breastfeeding, age under 18 and over 70 years, use of oral acne treatments in the past 6 months, skin infection such as impetigo or herpes simplex, history of severe skin disease, presence of active acne, history of Use of isotretinoin in the last 6 months, photosensivity
Intervention groups
The first group receiving radiofrequency and fractional co2 and the second group receiving radiofrequency
Main outcome variables
Patients were asked about their level of satisfaction with the intervention, and the answers were collected in the form of a Likert scale. Also, the severity of acne scars of patients is measured by an experienced dermatologist in follow-up sessions based on the quantitative scoring system of Baron and Goodman.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230426058003N1
Registration date: 2023-05-16, 1402/02/26
Registration timing: registered_while_recruiting

Last update: 2023-05-16, 1402/02/26
Update count: 0
Registration date
2023-05-16, 1402/02/26
Registrant information
Name
Sobhan Jangi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4471 6472
Email address
sosobhanso@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2024-01-01, 1402/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of fractional co2 laser and the use of radiofrequency devices on atrophic acne scars
Public title
Effectiveness of fractional co2 laser and radiofrequency on atrophic acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of complete patient information Consent to participate in the study Age over 18 years and under 70 years
Exclusion criteria:
Existence of disease background Pregnancy and breastfeeding Age below 18 and above 70 years Use of oral acne treatments in the past 6 months Suffering from a skin infection such as impetigo or herpes simplex History of severe skin disease Presence of active acne History of using isotretinoin in the last 6 months Photosensitivity
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random, Individual, Online random table
Blinding (investigator's opinion)
Not 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 Tehran Islamic Azad University Medical Sciences Branch
Street address
No.16 west, Gol Yach West St., Aineh Blvd., Shahid Pabarja St., Qalhak Crossroads, Shariati St.
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.IAU.TMU.REC.1402.031

Health conditions studied

1

Description of health condition studied
Atrophic acne scars
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The healing rate of atrophic scars
Timepoint
Patients are examined and evaluated at intervals of one month, two months and six months after the treatment.
Method of measurement
Patients were asked about their level of satisfaction with the intervention, and the answers were collected in the form of a Likert scale. Also, the severity of acne scars of patients is measured by an experienced dermatologist in follow-up sessions based on the quantitative scoring system of Baron and Goodman.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first intervention group received radiofrequency and fractional co2 and the second intervention group received radiofrequency. Each person is treated in 4 sessions with three-week intervals
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Farhikhtegan hospital
Full name of responsible person
Sobhan jangi
Street address
Shohadaye hesarak Blvd., Hesarak
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Fax
Email
Farhikhteganhospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir mahyar khoshsirat
Street address
No. 16 west, Gol Yakh ST., Iyane Blvd., Pabarja St., Qalhak Crossroads, Shariati St.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Sobhan jangi
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
NO. 16, Shirin St. Belanian St. Gouyabadi St. Zafar
City
Tehran
Province
Tehran
Postal code
1485933341
Phone
+98 21 4471 6472
Email
Sosobhanso@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sepideh Tehrani
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 101, Sarv St., Mirdamad Blvd., Jordan
City
Tehran
Province
Tehran
Postal code
1485933341
Phone
+98 21 8878 8919
Email
Tehrani42643@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sobhan Jangi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
NO. 16, Shirin St. Belanian St. Gouyabadi St. Zafar
City
Tehran
Province
Tehran
Postal code
1485933341
Phone
+98 21 4471 6472
Email
Sosobhanso@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 further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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