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IRCT20260619069876N1 IRCT 2026-10-01 Shiraz University of Medical Sciences Tranexamic Acid Mesotherapy in Treatment of Periorbital Wrinkles Evaluating the Efficacy of Tranexamic Acid Mesotherapy in Treatment of Periorbital Wrinkles: a Randomized Control Trial 2026-09-30 anticipated 20 Recruiting https://irct.ir/trial/93721 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Side allocation (right vs. left periorbital area receiving intradermal tranexamic acid vs. normal saline) will be determined using a permuted block randomization method with a fixed block size of 4 and an allocation ratio of 1:1. The allocation sequence will be generated using a validated web-based randomization service, Sealed Envelope (www.sealedenvelope.com), with a pre-specified documented random seed to ensure reproducibility. To ensure robust allocation concealment, the randomization key will be securely retained by an independent third party who is not involved in participant recruitment, clinical administration, or outcome evaluation. This individual will prepare identical 1-mL insulin syringes pre-filled with either tranexamic acid or normal saline, labeled uniformly with neutral codes as "Side A" and "Side B" corresponding to sequentially numbered, opaque, sealed envelopes. The treatment allocation will remain completely concealed from the participant, the injector, the outcome assessor, and the image analysis investigator until study completion and database lock, Blinding description: This clinical trial is designed as a double-blind study where both participants and outcome assessors remain blinded to treatment allocation: Participant Blinding: Participants will remain completely unaware of which periorbital side receives tranexamic acid (TXA) and which side receives normal saline. Both sides will undergo identical intradermal injection protocols using indistinguishable 1-mL insulin syringes with 30-gauge needles, equal injection volumes (0.1 mL per puncture), identical 1-cm spacing, and uniform injection techniques. Outcome Assessor Blinding: The two independent board-certified dermatologists evaluating periorbital wrinkles via the Wrinkle Severity Rating Scale (WSRS) on standardized photographs will be fully blinded to treatment allocation. Furthermore, 3D digital images acquired by the VisioFace system will be independently coded and analyzed by an investigator blinded to intervention assignments. Syringe Preparation & Masking: To eliminate administration bias, pre-filled syringes containing TXA or saline will be prepared by an independent third party who is not involved in treatment delivery or outcome evaluation. Syringes will be identically labeled with neutral designations ("Side A" and "Side B") matching the concealed allocation log, ensuring blinding is maintained until database lock and unblinding. 2-3 Periorbital wrinkles. Intervention 1: Intervention group: Intradermal injection (mesotherapy) of tranexamic acid (1 mL ampoules at a concentration of 100 mg/mL) is performed on one side of the periorbital area (randomly assigned to either the right or left side). Injections are administered using a 1 mL insulin syringe and a fine 30-gauge needle, delivering a dose of 0.1 mL per injection point at 1 cm intervals within the designated periorbital area (total volume of 1 to 1.5 mL per side per session). This procedure is carried out by a dermatologist over four consecutive sessions at one-week intervals. Intervention 2: Control group: Intradermal micro-injections of normal saline (0.9% sodium chloride as placebo) into the contralateral periorbital side (split-face design). Injections are administered using 1-mL insulin syringes with 30-gauge needles at a volume of 0.1 mL per puncture point spaced approximately 1 cm apart within the standardized periorbital region of interest (total volume 1.0–1.5 mL per side per session), utilizing a technique identical to the intervention side. The procedure is performed weekly for 4 consecutive sessions by a board-certified dermatologist. Yes - There is a plan to make this available What will be shared: Data/Document Title: Clinical data and VisioFace 3D images Sharing Details: Anonymized individual participant data (IPD)—including demographic characteristics, WSRS clinical scores, and VisioFace 3D images—will be made available upon reasonable request to the corresponding author following the publication of the main study. When: Access begins 6 months after publication of the study results and will remain available for a period of 2 years. To whom: Academic researchers and faculty members affiliated with recognized universities or medical research institutions with an approved protocol and defined research purpose. Conditions: Purpose: Permitted exclusively for secondary statistical analyses, systematic reviews, and meta-analyses related to skin rejuvenation. Conditions: Provision of a scientifically approved protocol with institutional ethics clearance; execution of a formal Data Use Agreement (DUA); strict prohibition of any re-identification attempts; prohibition of commercial use; and mandatory citation of the original publication. Where to obtain: Applicants must submit their written request and proposal via email to the student author of the thesis: Contact Person: Dr. Armin Gorjian Address: Dermatology Clinic, Shahid Faghihi Hospital, Zand Street, Shiraz, Shiraz University of Medical Sciences Email: Armingorjian1996@gmail.com Phone: 00987132351087 How to obtain: Submission of formal request, approved protocol, and ethics clearance to the corresponding author via email. Protocol review by the research team within 2–3 weeks.Upon approval, signing of a formal Data Use Agreement (DUA) by the applicant within 1 week.Delivery of de-identified data via secure email within 1 week post-signing (total expected timeframe: 3–5 weeks). Comments:
public Armin Gorjian
Zand street
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1087 armingorjian1996@gmail.com Shiraz University of Medical Sciences scientific Armin Gorjian
Zand street
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1087 armingorjian1996@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Clinically visible periorbital wrinkles (grade ≥2 on WSRS) Age between 30 and 60 years, any gender No cosmetic or rejuvenation procedures (laser, fillers, botulinum toxin, PRP, microneedling) within the past 3 months No topical anti-wrinkle or periocular cream use during the past week Willingness to refrain from any cosmetic procedures during the study period Ability to comply with study schedule and provide informed consent 30 years 60 years Both Pregnancy or lactation Current use of anticoagulants, hormonal contraceptives, or topical periocular anti-wrinkle creams History of malignancy, deep vein thrombosis, pulmonary embolism, or cerebrovascular accident Severe systemic illness or coagulation disorders Heavy smoking or excessive occupational UV exposure Any hypersensitivity to TXA or injection components Participant request to discontinue participation Occurrence of severe adverse events or intolerance to injections Non-compliance with study protocol (missed >1 consecutive session) L57.8 Other skin changes due to chronic exposure to nonionizing radiation Treatment - Other Placebo Intervention group: Intradermal injection (mesotherapy) of tranexamic acid (1 mL ampoules at a concentration of 100 mg/mL) is performed on one side of the periorbital area (randomly assigned to either the right or left side). Injections are administered using a 1 mL insulin syringe and a fine 30-gauge needle, delivering a dose of 0.1 mL per injection point at 1 cm intervals within the designated periorbital area (total volume of 1 to 1.5 mL per side per session). This procedure is carried out by a dermatologist over four consecutive sessions at one-week intervals. Control group: Intradermal micro-injections of normal saline (0.9% sodium chloride as placebo) into the contralateral periorbital side (split-face design). Injections are administered using 1-mL insulin syringes with 30-gauge needles at a volume of 0.1 mL per puncture point spaced approximately 1 cm apart within the standardized periorbital region of interest (total volume 1.0–1.5 mL per side per session), utilizing a technique identical to the intervention side. The procedure is performed weekly for 4 consecutive sessions by a board-certified dermatologist. Change in periorbital wrinkle volume compared to baseline. Timepoint: Baseline and 1 month after the completion of the 4th treatment session. Method of measurement: 3D digital imaging and software-based quantification using the VisioFace system (measured in px³) within a standardized region of interest (ROI). Change in periorbital wrinkle area and area percentage. Timepoint: Baseline, weekly during the 4 treatment sessions, and 1 month post-treatment. Method of measurement: Quantitative surface analysis using the VisioFace 3D imaging system (measured in px² and area percentage). Change in periorbital wrinkle depth. Timepoint: Baseline, weekly during treatment visits, and 1 month post-treatment. Method of measurement: Automated quantitative wrinkle depth measurement using calibrated VisioFace 3D imaging (in mm or pixels). Clinical severity of periorbital wrinkles. Timepoint: Baseline and 1 month after the final treatment session. Method of measurement: Independent evaluation of standardized clinical photographs by two blinded dermatologists using the 5-point Wrinkle Severity Rating Scale (WSRS, grades 1 to 5). Patient satisfaction with periorbital wrinkle improvement and aesthetic outcome. Timepoint: 1 month following the completion of treatment. Method of measurement: Self-administered questionnaire using a 5-point Likert scale (ranging from 1 = Very Dissatisfied to 5 = Very Satisfied). Incidence, nature, and severity of treatment-related local and systemic adverse events. Timepoint: At each weekly injection visit (Weeks 1 to 4) and at the 1-month post-treatment follow-up. Method of measurement: Clinical examination and patient reporting recorded on standardized Case Report Forms (CRFs), assessing local complications (erythema, edema, ecchymosis, papules) and ocular symptoms. Shiraz University of Medical Sciences Approved 2026-02-07 Ethics committee of Shiraz University of Medical Sciences Zand Street Shiraz Fars Iran (Islamic Republic of)