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IRCT20250325065152N2 IRCT 2025-09-24 Tehran University of Medical Sciences Comparison of the Efficacy and Adverse Effects of Fractional CO₂ Laser and Hyaluronic Acid Mesotherapy for Infraorbital Wrinkles Following Lower Blepharoplasty Comparison of the Efficacy and Adverse Effects of Fractional CO₂ Laser and Hyaluronic Acid Mesotherapy for Infraorbital Wrinkles Following Lower Blepharoplasty 2025-09-23 anticipated 24 Complete https://irct.ir/trial/85991 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Infraorbital Wrinkles Following Lower Blepharoplasty. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information on the main outcome will be published. When: Up to six months after results are published To whom: It will be available to researchers working in academic and scientific institutions as well as people working in industry. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Taha Shahbazi
Tehran - Vahdat-e-Islami Street - Vahdat-e-Islami Square - Razi Dead End - Razi Specialized Dermatology Hospital
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5288 8282 shahbazi.taha@yahoo.com Tehran University of Medical Sciences scientific Taha Shahbazi
Tehran - Vahdat-e-Islami Street - Vahdat-e-Islami Square - Razi Dead End - Razi Specialized Dermatology Hospital
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5288 8282 shahbazi.taha@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 30 years 65 years Both 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. Treatment - Surgery Treatment - Devices 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. 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. 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. Tehran University of Medical Sciences Approved 2025-04-27 Ethics Committee of the School of Medicine, Tehran University of Medical Sciences Room 604, 6th Floor, Central Building of Tehran University of Medical Sciences, Intersection of Quds Street, Keshavarz Boulevard, Tehran Tehran Tehran Iran (Islamic Republic of)