تعیین میزان اثربخشی و عوارض جانبی لیزرکیوسوئیچ ان دی یگ و فرکشنال اربیوم یگ در جوانسازی لب در بيماران مراجعه كنده به درمانگاه پوست بيمارستان شهداي تجريش
Design
A clinical trial study
Settings and conduct
The community under study in this research consists of patients visiting the skin clinic at Shahid Tajrish Hospital during the years 1403-1404. Patients who meet the necessary criteria to enter the study will be selected and divided into two groups: the first group will receive treatment with a Q-Switch laser for lip rejuvenation, while the second group will be treated with an Erbium laser. Patients will be evaluated during the first session (baseline), the second, and the third treatment, as well as one month and three months after the last laser session, based on the results measured by the photofinder and the lip fullness scale, along with digital photography. Additionally, each visit will assess satisfaction and any side effects, and patients are advised to return for a follow-up visit one week after the first laser treatment. They are also encouraged to report any side effects at any time during the study. The evaluation will be conducted using the photofinder by examining images taken uniformly and with standard quality at each stage to determine wrinkle, evenness, and UV damage.
Participants/Inclusion and exclusion criteria
Age between 30-70 years old
Intervention groups
Group one: Lip rejuvenation using Q-switched laser
Group two: Lip rejuvenation using Erbium laser
Main outcome variables
- Volume improvement of lips
- Color improvement of lips
- Texture improvement of lips
- Duration of burning and itching
- Duration of redness
- Duration of swelling
- Duration of blisters
- Duration of bleeding
- Duration of crusting
- Duration of hypopigmentation
- Duration of hyperpigmentation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240801062612N1
Registration date:2024-08-16, 1403/05/26
Registration timing:prospective
Last update:2024-08-16, 1403/05/26
Update count:0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Fateme Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3364 4893
Email address
fz.samadi@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2025-09-06, 1404/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Efficacy and side effects of Q switched Nd:YAG versus fractional Er:YAG in lip rejuvenation
Public title
Evaluation Efficacy and side effects of Q switched Nd:YAG versus fractional Er:YAG in lip rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 30-70 years.
Exclusion criteria:
History of keloid formation
History of clotting disorders or the use of medications that affect clotting
Uncontrolled diabetes or hypertension
Active herpes infection in the lip area within the past month
Lack of willingness or ability to attend follow-up appointments as scheduled
History of hereditary or acquired connective tissue diseases
History of skin cancer in the past 5 years
Unrealistic expectations
Use of other lip rejuvenation methods, including filler injections
Allergy to lidocaine or tetracaine
Fitzpatrick skin type >III
History of lichen planus
Lip shading and lip tattoo
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
People will enter the study using a convenience sampling method and will then be divided into two groups using simple random sampling with a number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Tehran, Shahid beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-06-12, 1403/03/23
Ethics committee reference number
IR.SBMU.REC.1403.008
Health conditions studied
1
Description of health condition studied
Rejuvenation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lip volume improvement amount
Timepoint
Entering study, one month later, three months later
Method of measurement
Comparison of the before and after image
2
Description
Improving lip color
Timepoint
Entering study, one month later, three months later
Method of measurement
Comparison of the before and after image
3
Description
Improving lip texture
Timepoint
Entering study, one month later, three months later
Method of measurement
Comparison of the before and after image
4
Description
side effects
Timepoint
Entering study, one month later, three months later
Method of measurement
Asking the patient and recording in the checklist
Secondary outcomes
1
Description
Hypopigmentation
Timepoint
starting the study, one month later, three months later
Method of measurement
Comparison of the before and after photos
2
Description
Hypopigmentation
Timepoint
starting the study, one month later, three months later
Method of measurement
Comparison of the before and after photos
3
Description
Scar
Timepoint
starting the study, one month later, three months later
Method of measurement
Comparison of the before and after photos
Intervention groups
1
Description
Intervention group: Intervention group: Individuals in the study group for rejuvenation will undergo Q-switched laser therapy over three sessions (at baseline, one month later, and three months later).
Category
Treatment - Other
2
Description
Control group: Intervention group: Individuals in the study group for rejuvenation will undergo Erbium YAG laser therapy over three sessions (at baseline, one month later, and three months later).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Fatemeh Samadi
Street address
Tajrish Square, Shohada Tajrish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
معاونت پژوهش دانشگاه علوم پزشکی شهید بهشتی
Street address
Tehran, Velenjak, Beheshti University of Medical Sciences Research Department
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Samadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tajrish, Shohada Tajrish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
fzsamadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Samadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tajrish, Shohada Tajrish, Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
fzsamadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Samadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tajrish, Shohada Tajrish Hospital
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
fzsamadi@yahoo.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
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
Title and more details about the data/document
Information about the rejuvenation results using these two lasers will be published in the form of a research article.
When the data will become available and for how long
Right now, we can't set a specific time for this, but as soon as the project is finished, the article based on that project will be ready.
To whom data/document is available
The general public
Under which criteria data/document could be used
The data is accessible for everyone.
From where data/document is obtainable
Shahid Beheshti University Skin Research Center
What processes are involved for a request to access data/document
Visit the skin research center and submit a request.