Comparison of the Efficacy and Adverse Effects of Fractional CO₂ Laser and Hyaluronic Acid Mesotherapy for Infraorbital Wrinkles Following Lower Blepharoplasty
This study aims to compare the efficacy and adverse effects of fractional carbon dioxide laser and hyaluronic acid mesotherapy in improving infraorbital wrinkles following lower blepharoplasty.
Design
Interventional clinical trial with two parallel groups, block randomization and single-blind design, planned sample size of 24 participants.
Settings and conduct
The study will be conducted at the dermatology clinic of Razi Hospital, Tehran University of Medical Sciences. Outcome assessors are blinded to group allocation.
Participants/Inclusion and exclusion criteria
Participants aged 30 to 65 years with measurable infraorbital wrinkles and at least one month after lower blepharoplasty; good general health. Exclusion: pregnancy or breastfeeding; allergy to study interventions; similar treatments in the past six months; active dermatologic or autoimmune disease; lack of compliance.
Intervention groups
Group 1: one session of fractional carbon dioxide laser with standard post-treatment care. Group 2: three sessions of hyaluronic acid injections at four-week intervals with standard care.
Main outcome variables
Severity of lower eyelid wrinkles using the standardized Lemperle scale at baseline, one, three and six months after intervention; recording and comparing adverse effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250325065152N2
Registration date:2025-09-24, 1404/07/02
Registration timing:registered_while_recruiting
Last update:2025-09-24, 1404/07/02
Update count:0
Registration date
2025-09-24, 1404/07/02
Registrant information
Name
Taha شهبازی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3323 2549
Email address
t.shahbazi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy and Adverse Effects of Fractional CO₂ Laser and Hyaluronic Acid Mesotherapy for Infraorbital Wrinkles Following Lower Blepharoplasty
Public title
Comparison of the Efficacy and Adverse Effects of Fractional CO₂ Laser and Hyaluronic Acid Mesotherapy for Infraorbital Wrinkles Following Lower Blepharoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 30 to 65 years who have undergone lower blepharoplasty.
Presence of visible and measurable wrinkles in the infraorbital area
At least one month has passed since the lower blepharoplasty procedure.
Good general health status with well-controlled systemic diseases and no active dermatological conditions.
Provision of written informed consent acknowledging awareness of the benefits, risks, and potential side effects of the treatment.
Exclusion criteria:
Pregnancy or breastfeeding
history of allergy to fractional CO₂ laser or mesotherapy agents
Previous injectable, laser, or other skin rejuvenation treatments in the infraorbital area within the past six months; any cosmetic intervention that may influence the outcome assessment.
Presence of skin infections, severe acne, or inflammatory skin diseases in the periorbital region; autoimmune disorders or uncontrolled diabetes.
Lack of patient compliance with treatment sessions or follow-up visits; psychological or behavioral conditions affecting accurate information sharing or adherence to the study protocol.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were recruited through convenience sampling from patients attending the dermatology clinic of Razi Hospital, Tehran University of Medical Sciences. Eligible individuals were screened by a dermatologist according to the inclusion and exclusion criteria, and written informed consent was obtained before enrollment. Patient names were recorded sequentially in an Excel file, and allocation into the two intervention groups was performed using block randomization with blocks of four, ensuring that within each block, two patients were assigned to the fractional CO₂ laser group and two to the mesotherapy protocol group. Randomization was conducted through a simple lottery method by the principal investigator: for each block, four slips of paper (two marked as Group 1: Fractional CO₂ Laser, and two marked as Group 2: Mesotherapy Protocol) were placed in a container, and an individual not otherwise involved in the study drew the slips to determine group assignments, thereby maintaining impartial allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is conducted with a single-blind design, in which only the outcome assessors remain unaware of the treatment group allocation. The patients and treatment providers are informed of the group assignments. To maintain assessor blinding, their access to treatment records or allocation-related information is restricted.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Medicine, Tehran University of Medical Sciences
Street address
Room 604, 6th Floor, Central Building of Tehran University of Medical Sciences, Intersection of Quds Street, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2025-04-27, 1404/02/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.111
Health conditions studied
1
Description of health condition studied
Infraorbital Wrinkles Following Lower Blepharoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The severity of lower eyelid wrinkles will be assessed using the standardized Lemperle Wrinkle Assessment Scale. This scale classifies the severity of each wrinkle into six grades from zero to five: 0: no wrinkle or completely smooth skin; 1: very superficial wrinkle barely visible at rest; 2: superficial but clearly visible wrinkle without significant depth; 3: moderate wrinkle, clearly visible with moderate depth; 4: deep wrinkle with well-defined edges but without skin overhang; 5: very deep wrinkle with marked skin overhang.
Timepoint
Measurement of the severity of lower eyelid wrinkles will be performed before the intervention (baseline) and then at one month, three months, and six months after the intervention.
Method of measurement
At each visit, standardized digital photographs of the lower eyelids of both eyes will be taken under fixed lighting, distance, and angle conditions. Two trained resident blinded evaluators will independently score these photographs using the standard Lemperle Wrinkle Assessment Scale from zero (no wrinkle) to five (very deep wrinkle), and the mean of the two scores will be recorded as the final value.
Secondary outcomes
empty
Intervention groups
1
Description
Patients in this intervention group will be treated with a Fractional CO₂ Laser device (EdgeONE, 120-µm spot size). Before treatment, the lower eyelid area will be carefully cleansed and standard photographs will be taken; to minimize pain and discomfort, a 5% lidocaine topical anesthetic cream will be applied under occlusion for 30–45 minutes and then completely removed. For ocular protection, either an intraocular metal shield or standard protective goggles will be used. The treatment will be performed using the following parameters: Density 0.5% (approximately 49 dots/cm²), Pulse Energy 15 mJ, Total Fluence 0.7 J/cm², Power 15 W, Stacking Times 1, Shot Interval 0.2 s, and a 15×15 random scan pattern. The entire treatment will be carried out in a single uniform pass, avoiding excessive overlap and maintaining at least a 1–2 mm distance from the lash line to prevent injury. After the laser session, cold compresses will be applied for 10–15 minutes, and a healing ointment plus a topical antibiotic will be prescribed for 2–3 days. From the third day onward, patients will be instructed to use a physical sunscreen and to avoid direct sunlight, saunas, and strenuous activity for two weeks; in the case of itching or prolonged erythema, a short course (3–5 days) of 1% hydrocortisone cream will be recommended. One treatment session will initially be performed, and response and adverse events will be evaluated at follow-up visits. The treatment schedule will run parallel to the second intervention group, with three sessions administered at four-week intervals.
Category
Treatment - Surgery
2
Description
Patients in this group will be treated with injections of non–cross-linked or low–cross-linked hyaluronic acid at a standard concentration. Prior to injection, the area will be carefully cleansed and disinfected, standard photographs will be taken, and if needed, topical anesthetic cream or mild lidocaine anesthesia will be administered. A single entry point will then be created in the lateral sulcus (approximately 1–1.5 cm lateral to the outer canthus) using a 25- or 23-gauge needle. A 27-gauge cannula of appropriate length (38–50 mm) will be introduced through the same entry point, and the product will be injected into the deep dermis and superficial subcutaneous layer over the orbicularis oculi muscle. Injections will be performed using a retrograde linear and micro-aliquot technique, with gentle aspiration before each injection to prevent intravascular placement. The injection volume per session will be 1 mL per side of the lower eyelid (2 mL total for both sides), with sessions repeated every four weeks for a total of three primary sessions. After injection, a very gentle massage will be applied to ensure even distribution, and a cold compress will be used for 10 minutes to minimize bruising and edema. Post-treatment care will include avoiding touching or applying makeup for 24 hours, sleeping with the head elevated on the first night, avoiding alcohol and strenuous activity on the same day, and promptly reporting any severe pain or skin discoloration. Patients will be monitored at follow-up visits for bruising, persistent edema, Tyndall effect, asymmetry, or excessive prominence, and if necessary, hyaluronidase administration will be available according to the center’s protocol.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
طاها شهبازی
Street address
Vahdat-e-Islami Street – Vahdat-e-Islami Square – Razi Dead End – Razi Specialized Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
dr.shakoei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamid kordi
Street address
6th Floor, Vice-Chancellery for Research and Technology, Central Building of Tehran University of Medical Sciences, Intersection of Quds Street, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Fax
+98 21 8898 9664
Email
tumspr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Taha Shahbazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tehran - Vahdat-e-Islami Street - Vahdat-e-Islami Square - Razi Dead End - Razi Specialized Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
shahbazi.taha@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Taha Shahbazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tehran - Vahdat-e-Islami Street - Vahdat-e-Islami Square - Razi Dead End - Razi Specialized Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
shahbazi.taha@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Taha Shahbazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tehran - Vahdat-e-Islami Street - Vahdat-e-Islami Square - Razi Dead End - Razi Specialized Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
shahbazi.taha@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome will be published.
When the data will become available and for how long
Up to six months after results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions as well as people working in industry.
Under which criteria data/document could be used
The applicant must have a letter of introduction from an academic or industrial institution to access the information. The letter of introduction must also clearly state the purpose of accessing the information and the possible outcome of it.
From where data/document is obtainable
The project's general accountability officer will be contacted for information. Information: Dr. Taha Shahbazi Address: Razi Hospital Contact number: 09123485423 Zip code: 1199663911 Email: shahbazi.taha@yahoo.com
What processes are involved for a request to access data/document
First, the applicant must provide a letter of introduction from the university or company to access the information via email. After reviewing the request, the information file will be emailed to them within two weeks.