Evaluation of the efficacy of fractional CO2 laser in combination with 5-fluorouracil cream compared to PDL laser in the treatment of hypertrophic and keloidal scars: A randomized controlled clinical trial
Determining the effectiveness of fractional CO2 laser in combination with 5-fluorouracil cream compared to PDL laser in the treatment of hypertrophic and keloid scars.
Design
Clinical trial with parallel groups, single-blind, randomized, phase 2 on 24 patients, simple randomization was used for randomization.
Settings and conduct
The selected patients will have at least 2 erythematous or keloid hypertrophic scar lesions, with a minimum size of 5x5 cm2 or with a length of at least 5 cm will refer to the laser center of Tehran Hazrat Fatemeh Hospital and will be subjected to one of the following treatments:
1. PDL (Pulse Dye Laser) laser treatment (control intervention)2. Fractional CO2 laser treatment in combination with 5-fluorouracil cream
The treatment period for the first group is 3 sessions with an interval of 1 month and for the second one 3 sessions with an interval of 1 month with the use of 5FU cream for 5 days after each session
Participants/Inclusion and exclusion criteria
1. Age over 18 years
2. Patients with at least 2 hypertrophic scars
3. The size at least 5x5 cm square or the length is at least 5 cm
4. The patient is not pregnant or breastfeeding.
5. During the last two months, the patient has not received any treatment for the lesions
6. No diseases such as diabetes
7. The patient's cooperation in carrying out therapeutic interventions and referring for all therapeutic sessions
Intervention groups
1. Treatment with PDL (Pulse Dye Laser) (control intervention) 2. Fractional CO2 laser treatment with 5-fluorouracil cream
The length of the treatment period for the first group is 3 sessions with an interval of 1 month and for the second group 3 sessions with an interval of 1 month along with the use of 5FU cream for 5 days after each treatment session.
Main outcome variables
Effectiveness of treatment; safety of treatment; Tolerability of treatment; satisfaction with treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190901044666N4
Registration date:2023-01-18, 1401/10/28
Registration timing:registered_while_recruiting
Last update:2023-01-18, 1401/10/28
Update count:0
Registration date
2023-01-18, 1401/10/28
Registrant information
Name
Afsaneh Sadeghzadeh bazargan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2421
Email address
sadeghzadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-17, 1401/10/27
Expected recruitment end date
2023-04-16, 1402/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of fractional CO2 laser in combination with 5-fluorouracil cream compared to PDL laser in the treatment of hypertrophic and keloidal scars: A randomized controlled clinical trial
Public title
Effect of fractional CO2 laser in combination with 5-fluorouracil cream compared to PDL laser in the treatment of hypertrophic and keloidal scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old
Patients with a confirmed diagnosis of erythematous hypertrophic scar in the number of at least 2
The size of the waste should be at least 5x5 cm square or have a length of at least 5 cm
The patient is not pregnant or breastfeeding
During the last two months, the patient has not received any treatment for the lesions, including laser treatment, topical or injectable corticosteroids
The patient has no underlying diseases that lead to scar healing process; such as diabetes or weakened immune system
The patient's cooperation in carrying out therapeutic interventions and referring for all therapeutic sessions
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple randomization method, the patients who refer to the laser clinic of Hazrat Fatemeh Hospital are placed in 2 groups in such a way that one envelope is randomly selected for each patient from the number of 24 sealed envelopes. Inside each envelope is the letter A or B. Group A patients will be treated with PDL laser and group B patients will be treated with fractional CO2 laser in combination with 5FU cream.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the clear difference between the mentioned therapeutic interventions, it was not possible to blind the therapist and the patients, and as a result, the study will be conducted in a one-sided blind manner. In other words, the evaluation of the results of the studies will be done by an evaluator who is blind to the type of intervention (a dermatologist who does not know which treatment group the patient is in) and based on the images taken of the lesions in each session. Also, data analysis will be done by a blinded statistician
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Rasoul Akram Hospital, At the corner of Mansouri St, Niayesh St, Satarkhan St
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Approval date
2022-11-23, 1401/09/02
Ethics committee reference number
IR.IUMS.FMD.REC.1401.435
Health conditions studied
1
Description of health condition studied
Hypertrophic scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Effectiveness of treatment on scar
Timepoint
Scar score measurement at the beginning of the study (before the start of the intervention) and after the end of the third session of the intervention (3 months later)
Method of measurement
Vancouver scar scale (VSS) scoring method will be used to check the effectiveness of the treatment. This scale includes examination of 4 characteristics of the lesion, including: vascularity, pigmentation, height and flexibility, which are scored for each characteristic and the sum of all points will be checked in order to evaluate the improvement of the lesion.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fractional CO2 laser treatment in combination with 5FU cream: Before the intervention, gentle cleaning of the desired lesion will be done using gauze soaked in normal saline. Then 60 minutes before the laser treatment, local anesthetic cream containing 2.5% lidocaine and 2.5% prilocaine (Xyla-P, Tehran Chemie, Tehran, Iran) will be applied on the lesion. At the end of 60 minutes, the local anesthetic cream will be removed using alcohol cotton. Then fractional CO2 laser will be applied using Deka SmartXide DOT (Deka, Florence, Italy) laser device (with power 14, stack 2, space 600 and dwell time 600) in each lesion area of 5x5 cm2. Immediately after laser treatment, five percent 5FU cream is used in the lasered area and this treatment will continue twice a day for 5 days.
Category
Treatment - Drugs
2
Description
Control group: PDL laser treatment:Before the intervention, gentle cleaning of the desired lesion will be done using gauze soaked in normal saline. Then PDL laser using Deka Alexandrite laser device (Synchro VasQ, Deka, Florence, Italy) with spot size of 7 mm, single duration of 0.5 milliseconds and power of 7 J/cm2 with 50 shots per 5x5 lesion area Square centimeters will apply.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Plastic and Reconstructive Surgery Hospital
Full name of responsible person
Mahta Mirhashemi
Street address
No. 23, West 21th Street, Yousef Abad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
crtfatima@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghzadeh bazargan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2421
Fax
Email
sadeghzadeh.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghzadeh bazargan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2421
Fax
Email
sadeghzadeh.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghzadeh bazargan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2421
Fax
Email
sadeghzadeh.a@iums.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