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IRCT20260801070468N1 IRCT 2026-09-20 Ahvaz University of Medical Sciences Comparison of glutathione mesotherapy and tranexamic acid mesotherapy for treatment of melasma Comparison of the effectiveness of mesotherapy with glutathione versus mesotherapy with tranexamic acid in the treatment of patients with melasma 2026-10-03 anticipated 42 Recruiting https://irct.ir/trial/92093 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Given the split-face study design, randomization was performed to determine which side of the face (left or right) would receive each of the two interventions; consequently, each participant received both interventions on opposite sides of the face. The allocation sequence was generated prior to participant enrollment using the "Sealed Envelope" online system, which randomly determined the order of the two possible allocation scenarios (Intervention A on the left and Intervention B on the right, or Intervention B on the left and Intervention A on the right). A randomization code was then assigned to each participant, dictating the random allocation of the left and right sides of the face to Interventions A and B. Allocation codes remained concealed from the researchers responsible for participant enrollment and outcome assessment until the time of allocation, ensuring that the assignment could not be predicted beforehand, Blinding description: This study is double-blinded. The participants (patients), the clinical caregiver (injecting physician), and the outcome assessor (MASI scoring physician) are blinded to the treatment group assignment. Blinding is implemented by an independent research associate who is not involved in the patient assessment process, using a random number table, determining which side of the face will be treated with each drug and preparing the drugs in identical, coded syringes (coded A and B). The coded syringes are then provided to the injecting physician to perform the injection process. The injecting physician is unaware of the type of drug injected. The patient (participant) is also unaware of the type of drug injected into each side of the face and does not know which side was treated with which drug. The evaluator (scorer) who scores the MASI and PGA before and after treatment is completely unaware of the treatment allocation and coding of the syringes and only reviews the photographs taken and the patient's clinical condition. Therefore, in this study, the three groups including the participants (patients), the clinical caregiver (injecting physician), and the outcome assessor (scoring physician) are blinded to the treatment group allocation, and only an independent research associate who has no role in the patient assessment process is aware of the coding of the syringes and random allocation. Blinding is done with the full knowledge of the participants and obtaining written informed consent. 3 Melasma. Intervention 1: Intervention group 1: One half of each participant's face, randomly selected, will undergo glutathione mesotherapy from the manufacturer Sina Darou. The injection will be performed intradermally with a 30-gauge needle (insulin syringe), at a depth of approximately 1 mm, with a volume of 0.05 ml at each point, and with a distance of approximately 1 cm between injection points. The injection solution will be diluted with 10% 2% lidocaine according to the study protocol, and the intervention will be performed in 5 sessions with an interval of two weeks. The patient will be evaluated before each session and will be examined for side effects including erythema, edema, and ecchymosis after each session. Intervention 2: Intervention group 2: Tranexamic acid with the chemical formula C₈H₁₅NO₂ at a concentration of 4 mg/ml (manufactured by Aburayhan Pharmaceutical Company, Iran) is diluted with 2% lidocaine at a ratio of 10:1. The dosage administered in each session is 2 ml of the final solution (containing 8 mg of pure tranexamic acid), which is injected as intradermal microinjection using a 1 ml insulin syringe with a 30-gauge needle at points spaced 1 cm apart, with a volume of 0.05 ml per point and a depth of 1 mm. Treatment sessions are conducted in 5 sessions at 2-week intervals (weeks 0, 2, 4, 6, and 8). Pre-injection care includes application of topical anesthetic cream (Xylapin) for 20 minutes, and post-injection care includes daily use of sunscreen with SPF 50 and avoidance of direct sunlight for 48 hours. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Still undecided - no release schedule yet
public Tara Barat
Imam Khomeini Hospital., 24 Meters., Azadegan St
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 601 7803 barat-t@ajums.ac.ir Ahvaz University of Medical Sciences scientific Tara Barat
Imam Khomeini Hospital., 24 Meters., Azadegan St
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 601 7803 barat-t@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Female patients aged 18–60 years with bilateral symmetrical facial melasma Not receiving treatment for melasma within three months prior to study entry Willingness to participate in the study Signing a written informed consent form 18 years 60 years Female Pregnant or breastfeeding women Use of oral contraceptive pills during the previous 12 months or planned use during the study period History of coagulation disorders or thrombotic diseases Current use of anticoagulant or anticonvulsant medications Known hypersensitivity to the study medications or topical lidocaine Presence of active infectious skin diseases, such as warts or active herpes, at the treatment site History of systemic diseases associated with hyperpigmentation L81.1 Chloasma Treatment - Drugs Treatment - Drugs Intervention group 1: One half of each participant's face, randomly selected, will undergo glutathione mesotherapy from the manufacturer Sina Darou. The injection will be performed intradermally with a 30-gauge needle (insulin syringe), at a depth of approximately 1 mm, with a volume of 0.05 ml at each point, and with a distance of approximately 1 cm between injection points. The injection solution will be diluted with 10% 2% lidocaine according to the study protocol, and the intervention will be performed in 5 sessions with an interval of two weeks. The patient will be evaluated before each session and will be examined for side effects including erythema, edema, and ecchymosis after each session. Intervention group 2: Tranexamic acid with the chemical formula C₈H₁₅NO₂ at a concentration of 4 mg/ml (manufactured by Aburayhan Pharmaceutical Company, Iran) is diluted with 2% lidocaine at a ratio of 10:1. The dosage administered in each session is 2 ml of the final solution (containing 8 mg of pure tranexamic acid), which is injected as intradermal microinjection using a 1 ml insulin syringe with a 30-gauge needle at points spaced 1 cm apart, with a volume of 0.05 ml per point and a depth of 1 mm. Treatment sessions are conducted in 5 sessions at 2-week intervals (weeks 0, 2, 4, 6, and 8). Pre-injection care includes application of topical anesthetic cream (Xylapin) for 20 minutes, and post-injection care includes daily use of sunscreen with SPF 50 and avoidance of direct sunlight for 48 hours. Melasma Area and Severity Index score. Timepoint: Before treatment initiation and at weeks 4, 8, and 12 after treatment initiation. Method of measurement: Assessment of the Melasma Area and Severity Index using the standardized Melasma Area and Severity Index scoring system by a dermatologist. Patient Global Assessment score. Timepoint: Before treatment initiation and at weeks 4, 8, and 12 after treatment initiation. Method of measurement: Assessment of the Patient Global Assessment using a standardized scoring scale by a dermatologist. Physician Global Assessment (PGA) score. Timepoint: Weeks 4, 8, and 12 after the start of the study. Method of measurement: Comparison of before and after treatment photos by the evaluating physician based on the grading of Excellent (75% improvement), Good (51-75%), Fair (26-50%), and Poor (0-25%). Incidence of adverse events related to mesotherapy. Timepoint: Immediately after each treatment session and until the end of the study period. Method of measurement: Review and record of complications including erythema, edema, ecchymosis, pain, and local sensitivity by the treating physician. Patient satisfaction score. Timepoint: End of treatment period (week 12). Method of measurement: Questioning the patient based on a 5-point scale (1: Dissatisfied, 2: Slightly satisfied, 3: Relatively satisfied, 4: Good satisfaction, 5: Completely satisfied). Melasma recurrence rate at 3 months after treatment. Timepoint: 3 months after the last treatment session (week 24). Method of measurement: Recalculation of MASI Score and comparison with previous scores by the evaluating physician. Ahvaz University of Medical Sciences Approved 2026-07-25 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Medical Sciences، Golestan St، Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)