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Comparison of 1064nm Q-Switched laser accompanied by topical isotretinoin and 1064nm Q-Switched laser alone for the treatment of acne scars in patients referred to dermatology clinic

Protocol summary

Study aim
Comparison of the combined effect of 1064nm Q-Switched laser and topical isotretinoin with 1064nm Q-Switched laser alone in the treatment of acne scars
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, phase 3 on 20 patients, the sample size due to split face method is 40, Randomization using random allocation.
Settings and conduct
Each intervention is performed on one side of the face, randomly, one side will receive only Q-switch laser and the other side will receive Q-switch laser along with topical isotretinoin. The laser sessions are three sessions at an interval of two weeks with a wavelength of 1064 nm and a fluence of 2 to 4 joules and 2 passes at each point, and topical isotretinoin should be used at night on clean skin, left on the skin for half an hour, and then washed off. Then, after 3 and 6 months, the healing rate of acne scar is determined by the observer with the help of photo finder system. The place of study is Alzahra skin clinic in Isfahan
Participants/Inclusion and exclusion criteria
Inclusion: Consent to enter the study, over 18 years old, suffering from almost identical scars on both sides of the face, mild to moderate acne without the need for systemic isotretinoin, patient skin type 1 to 4 Ineligibility: History of keloids or excess flesh, breastfeeding or pregnancy, suffering from severe systemic diseases, uncontrolled diabetes or malignancy.
Intervention groups
In each person, the face is divided into two parts in such a way that randomly one side of the face will receive only Q-switch laser and the other side of the face will receive Q-switch laser plus topical isotretinoin.
Main outcome variables
The better effect of combined laser and isotretinoin treatment in improving the disease; preventing the formation of acne scars and improving acne scars; Optimum use of lasers with less side effects and less invasive

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110501006350N2
Registration date: 2024-07-24, 1403/05/03
Registration timing: registered_while_recruiting

Last update: 2024-07-24, 1403/05/03
Update count: 0
Registration date
2024-07-24, 1403/05/03
Registrant information
Name
Arghavan Mokhtarian
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1626 1811
Email address
g_faghihi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 1064nm Q-Switched laser accompanied by topical isotretinoin and 1064nm Q-Switched laser alone for the treatment of acne scars in patients referred to dermatology clinic
Public title
Q-Switched laser accompanied by topical isotretinoin in treatment of acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Age above 18 Almost identical acne scars on both sides of face Mild to moderate acne without need to systemic isotretinoin in treatment Skin type 1-4
Exclusion criteria:
History of skin keloid Breastfeeding or pregnancy Severe systemic diseases, uncontrolled diabetes mellitus or cancers
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 2
in each person, the face is divided into two parts (split face method) and by using Random Allocation, each intervention is performed on one side of the face randomly. One side of the face will receive only the Q-switch laser and the other side of the face will receive the Q-switch laser along with topical isotretinoin.
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 20 patients is randomly selected from eligible patients. Each group of 20 people is sampled so that in each person, the face is divided into two parts (split face method) and by using Random Allocation, each intervention is performed on one side of the face randomly. One side of the face will receive only the Q-switch laser and the other side of the face will receive the Q-switch laser along with topical isotretinoin.
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 Isfahan University of Medical Sciences
Street address
Dermatology department, Alzahra hospital, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.MUI.MED.REC.1402.404

Health conditions studied

1

Description of health condition studied
Acne disease, Acne scar
ICD-10 code
L70
ICD-10 code description
Acne

Primary outcomes

1

Description
Acne scar change percentage
Timepoint
At the beginning of the study, after 3 and 6 months of the intervention
Method of measurement
Based on the Photo finder system (quantitative score analysis and a continuous score called evenness are available, which is recorded from the surface roughness profile, this interpretation and processing is done and the corresponding score is recorded)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: One side of the patient's face will receive Q-switch laser along with topical isotretinoin. Laser sessions are performed three sessions at an interval of two weeks with a wavelength of 1064 nm and a fluence of 2 to 4 joules and two passes at each point, and the method of using topical isotretinoin is that it should be used at night on clean skin so that it lasts for a long time. Leave it on the skin for half an hour and then wash it off.
Category
Treatment - Other

2

Description
Control group: one side of the face only receives Q-switch laser. Laser sessions are performed three times every two weeks with a wavelength of 1064 nm and a fluence of 2-4 joules and two passes at each point.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Gita Faghihi
Street address
Alzhara hospital, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
g_faghihi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Isfahan University of Medical Sciences, Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
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
Gita Faghihi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology department, Alzahra hospital, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
G_faghihi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gita Faghihi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology department, Alzahra hospital, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
G_faghihi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gita Faghihi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology department, Alzahra hospital, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
G_faghihi@med.mui.ac.ir

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
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