Comparison of fractional co2 laser therapy alone and with its combination with topical timolol or topical insulin in the treatment of acne scar, A randomized controlled clinical trial
Comparison of fractional co2 laser therapy alone and with its combination with topical timolol or topical insulin in the treatment of acne scar
Design
A clinical trial with two treatment groups along with the control group (opposite side of the patient's face), with parallel groups, double-blind, randomized, phase 3 on 30 patients. Random Allocation Software is used for randomization.
Settings and conduct
This study is conducted on patients with acne scars who are referred to skin clinics of Shiraz University of Medical Sciences. Patients' lesions are randomly divided into two groups (right and left lesions). The plan is implemented in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. The patients with moderate to severe atrophic acne scarring and no inflammatory lesions 2. Age above 15 years old. Exclusion criteria: 2. Pregnant and lactating patients 2. Patients who have inflammatory lesions patients who have active Koebner-inducing diseases such as psoriasis and Lichen planus 3. Patients who have Asthma, atrioventricular blocks, sinus bradycardia, diabetes mellitus 4. Prior use of beta blockers, 5. The patients who have received Isotretinoin in the past three months.
Intervention groups
Group A lesions will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical Timolol Maleate ۰.۵% on the other side. Group B lesions will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical regular insulin on the other side. The mode of the fractional CO۲ device will be set to: Power: ۱۲, Stack:۲, Scanning dwell time: ۷۰۰, and Spacing: ۷۰۰. All of the patients will be asked to participate in three sessions of laser therapy at three-week intervals.
Main outcome variables
Acne Scar Assessment Scale (ASAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N23
Registration date:2024-01-17, 1402/10/27
Registration timing:registered_while_recruiting
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-31, 1402/10/10
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fractional co2 laser therapy alone and with its combination with topical timolol or topical insulin in the treatment of acne scar, A randomized controlled clinical trial
Public title
Comparison of fractional co2 laser therapy alone and with its combination with topical timolol or topical insulin in the treatment of acne scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with moderate to severe atrophic acne scarring and no inflammatory lesions
Age above 15 years old
Exclusion criteria:
Pregnant and lactating patients
Patients who have inflammatory lesions
Patients who have active Koebner-inducing diseases such as psoriasis and Lichen planus
Patients who have Asthma, atrioventricular blocks, sinus bradycardia, diabetes mellitus
Prior use of beta blockers,
The patients who have received Isotretinoin in the past three months.
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will follow a permuted block method, including 12 blocks of four, achieved by Random Allocation Software. In this regard, the lesions are divided into two groups A (right side of the face) and B (left side of the face). Dark-colored envelopes will be used to hide random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The used drugs will be poured into similar containers that will be tagged for A and B so that the resident and the patient will be ignorant of the applied medication. Only the secretary of the dermatology department will know the medication of each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical School of Shiraz University of Medical Sciences
Street address
Medical School of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.SUMS.MED.REC.1402.324
Health conditions studied
1
Description of health condition studied
Acne scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Severity of acne scar
Timepoint
At the beginning of the study and after two months
Method of measurement
Scale for Acne Scar Severity (SCAR-S),
2
Description
Acne Scar Assessment Scale
Timepoint
At the beginning of the study and after two months
Method of measurement
Acne Scar Assessment Scale (ASAS)
3
Description
Grading of scar
Timepoint
At the beginning of the study and after two months
Method of measurement
Goodman and Baron quantitative global scarring grading system (GBAQGS).
Secondary outcomes
1
Description
Dermatologic Life Quality Index
Timepoint
At the beginning of the study and after two months
Method of measurement
Dermatologic Life Quality Index (DLQI) questionnaire
Intervention groups
1
Description
Intervention group: Group A will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical Timolol Maleate ۰.۵% on the other side. The mode of the fractional CO۲ device will be set to: Power: ۱۲, Stack:۲, Scanning dwell time: ۷۰۰, and Spacing: ۷۰۰.
Category
Treatment - Drugs
2
Description
Intervention group: Group B will receive fractional CO۲ laser therapy with distilled water on one side and the combination of fractional CO۲ laser therapy and topical regular insulin on the other side. The mode of the fractional CO۲ device will be set to: Power: ۱۲, Stack:۲, Scanning dwell time: ۷۰۰, and Spacing: ۷۰۰.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Dermatology Clinic
Full name of responsible person
Dr. Nasrin Saki
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348466114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hashem Hashempur
Street address
Shiraz University of medical Sciences, Research vice, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7252
Email
Hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sara Sadat Alavizadeh
Position
Dermatology Resident
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand Streat, Shahid Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
009832125592
Email
alavizadeh.sarah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nasrin Saki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
One year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews.
From where data/document is obtainable
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
What processes are involved for a request to access data/document
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
Comments
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.