Determining the effectiveness of ENDOLIFT laser compared to botulinum toxin injection in the treatment of neck wrinkles
Design
Volunteer patients with complaints of neck wrinkles who meet the inclusion criteria will be included in the study after obtaining informed consent. This study is a two-group, single-center, parallel, randomized clinical trial study with outcome assessor blinding.
Settings and conduct
Volunteer patients with complaints of neck wrinkles who meet the inclusion criteria will be included in the study after obtaining informed consent. This study is a two-group, single-center, parallel, randomized clinical trial study with outcome assessor blinding. Patients will be randomly assigned to one of the groups with a ratio of 1:1. Group A will include patients whose neck wrinkles will be treated with endolift laser. And group B will include patients whose botulinum toxin will be used to help remove their scars.
Participants/Inclusion and exclusion criteria
Entry requirements:
Age range 40 to 65 years
Evaluation of wrinkles by a doctor and confirmation of the patient's beautification intervention candidate
People who are candidates for surgery or unwilling to undergo surgery
All participants provided oral as well as written informed consent
Non-entry conditions:
Pregnancy and breastfeeding
Neuromuscular failure
Hypersensitivity to Botox or laser
infection
Intervention groups
Patients will be randomly assigned to one of the groups with a ratio of 1:1. Group A will include patients whose neck wrinkles will be treated with endolift laser. And group B will include patients whose botulinum toxin will be used to help remove their scars.
Main outcome variables
Modified Global Aesthetic Improvement Scale (GAIS); Fitzpatrick Wrinkle and Elastosis Scale; 5-point wrinkle grading scale; Investigators assessed side effects; Patients' satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027636N7
Registration date:2024-07-10, 1403/04/20
Registration timing:registered_while_recruiting
Last update:2024-07-10, 1403/04/20
Update count:0
Registration date
2024-07-10, 1403/04/20
Registrant information
Name
Ghasem Rahmatpour Rokni
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3322 1755
Email address
gh.rahmatpour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of ENDOLIFT laser versus Botulinum toxin in Treatment of Horizontal Neck LINES: Randomized Clinical Trial
Public title
"Efficacy of ENDOLIFT in treatment of horizontal neck lines" "Botulinum toxin in treatment of horizontal neck lines"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40 to 65 years
Evaluation of wrinkles by a doctor and confirmation of the patient's cosmetic intervention candidate
All participants provided oral as well as written informed consent
Exclusion criteria:
Pregnancy and breastfeeding
Neuromuscular failure
Hypersensitivity to Botox or laser
infection
Age
From 40 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of the groups with a ratio of 1:1. Group A will include patients whose neck wrinkles will be treated with endolift laser. And group B will include patients whose botulinum toxin will be used to help remove their scars.
The randomization list of patients will be generated using the block balanced randomization method with the help of the Randomization.com website from the original generator section with blocks of 4. Then the created lists will be entered in the sealed envelopes in order. After preparing the sealed envelopes, the list will be destroyed. The blinding of the evaluators, who are two separate dermatologists, will be done by showing the before and after photos of the patients, and these two evaluators will be completely unaware of the intervention process.
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
Research Ethics committee of Mazandaran University of Medical Sciences
Street address
Sari, Baran Clinic, 15 Khordad Av.
City
Sari
Province
Mazandaran
Postal code
1234567898
Approval date
2024-02-28, 1402/12/09
Ethics committee reference number
IR.MAZUMS.REC.1402.712
Health conditions studied
1
Description of health condition studied
Horizontal Neck Lines
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Modified Global Aesthetic Improvement Scale (GAIS)
Timepoint
3 months after the intervention
Method of measurement
Assessment by the researcher (physician) - Modified Global Aesthetic Improvement Scale (GAIS). Six different levels of aesthetic improvement, ranging from “Very Much Improved” to “Very Much Worse.” Each of these ratings has a corresponding description in the “Description” column, which explains the degree of improvement or worsening in appearance.Here’s a brief summary of the table: Very Much Improved: Optimal cosmetic result from this procedure in this subject Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject Improved: Obvious improvement in appearance from the initial condition No Change: The appearance is essentially the same as the original condition Worse: The appearance is worse than the original condition Much Worse: The appearance is much worse than the original condition Very Much Worse: The appearance is very much worse than the original condition
Secondary outcomes
1
Description
The Wrinkle and Elastosis
Timepoint
At the beginning of the study, 3 months after the intervention
Method of measurement
Assessment by the researcher (physician) - The Fitzpatrick Wrinkle and Elastosis Scale (FWES) is a clinical tool used to assess the severity of wrinkles. It has been modified over time to improve its reliability and applicability.The Modified Fitzpatrick Wrinkle Scale (MFWS) is a validated measurement tool for nasolabial wrinkle severity assessment. It comprises three main classes and three interclasses, with definitions based on a set of reference photographs and descriptions. The scale has demonstrated good inter- and intra-assessor reliability.The FWES, on the other hand, categorizes wrinkle and elastosis severity into three levels: Mild (1-3): Fine texture changes with subtly accentuated skin lines Moderate (4-6): Distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia Severe (7-9): Multipapular and confluent elastosis (thickened, yellow and pallid) approaching or consistent with cutis rhomboidalis3These scales are used in clinical settings to assess the effectiveness of treatments for wrinkles and other signs of skin aging. They provide a standardized method for quantifying wrinkle depth and severity, which is crucial for evaluating the efficacy of cosmetic techniques and treatments.
2
Description
wrinkles
Timepoint
Assessment by the researcher (physician)
Method of measurement
Assessment by the researcher (physician) - 5-point wrinkle grading scale - The Score column lists numbers from 0 to 4, each representing a different level of wrinkle severity. The Description column provides details for each score: Score 0 (none): “No wrinkles.” Score 1 (mild): “Fine wrinkles; continuous skin line.” Score 2 (moderate): “Visible wrinkles and slight indentation.” Score 3 (severe): “Clearly visible wrinkles.” Score 4 (extreme): “Deep and furrowed wrinkles” and also includes the phrase “Extremely deep and long folds.”This table provides a standardized scale for grading the severity of skin wrinkles, which could be useful in dermatology or cosmetic science for assessing skin condition or the effectiveness of anti-aging treatments
3
Description
Patients' satisfaction
Timepoint
3 months after the intervention
Method of measurement
Patient reported outcome - Patients' satisfaction - A 4- point patient satisfaction scale was used to evaluate the post- treatment patient satisfaction as follows: 0 = not satisfied, 1 = moderately satisfied, 2 = satisfied, 3 = very satisfied.11 Patient satisfaction was evaluated 3 months after injection.
4
Description
side effects
Timepoint
From the beginning of the intervention to the end of three months after that
Method of measurement
Assessment by the researcher (physician)
Intervention groups
1
Description
Intervention group: The patients who endolift laser will be used for neck wrinkles. Laser endolift with characteristics (EUFOTON, Via Flavia 23/1 - 34148 Trieste (TS) Italy) with settings POWER=1.5 tOn=25 tOff=75 will be used once at the beginning of the study.
Category
Treatment - Other
2
Description
Control group: patients who botulinum toxin (BOTOX) will be used to help remove their wrinkles. A 500 unit vial of MASPORT brand abobotulinumtoxin A will be reconstituted by adding 2.5 cc of sterile normal saline. We will use 1 ml syringes with 30 gauge needles for injection. Then, intradermal injection of Dysport bolus (4 to 6 units in each point) at a distance of 1-1.5 in the horizontal lines of the neck will be done once for all participants.
NO.2 Building of Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Email
Bou_Ali_hospital@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
20
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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Malekan
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golestan Ave. 8th
City
SARI
Province
Mazandaran
Postal code
4896413254
Phone
+98 911 755 4873
Email
malekan.mohammad78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Malekan
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golestan Ave. 8th
City
SARI
Province
Mazandaran
Postal code
4896413254
Phone
+98 911 755 4873
Email
malekan.mohammad78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ghasem Rahmatpour Rokni
Position
Assistant Professor of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bu-Ali Sina hospital
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3322 1755
Fax
Email
dr.rokni@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
The study report in the form of an article, the English protocol of the study and the raw data of the study will be available for publication after completion.
When the data will become available and for how long
Permanently
To whom data/document is available
All readers and researchers
Under which criteria data/document could be used
For transparency and reuse in systematic analyses
From where data/document is obtainable
Mohammad Malekan malekan.mohammad78@gmail.com
What processes are involved for a request to access data/document
By email with the approval of the group active in the study