Comparison of the effectiveness of mesotherapy with glutathione versus mesotherapy with tranexamic acid in the treatment of patients with melasma

Comparison of the effectiveness of mesotherapy with glutathione versus mesotherapy with tranexamic acid in the treatment of patients with melasma

A randomized, double-blind, parallel-group, phase III clinical trial was conducted in 42 patients. Randomization was performed using a random number table.

The study will be conducted at the Dermatology Clinic of Imam Khomeini Hospital, Ahvaz. After obtaining informed consent, eligible patients will be randomly assigned to undergo glutathione and tranexamic acid mesotherapy on both sides of the face with the same injection protocol. Evaluation of response to treatment and complications will be performed in a double-blind manner, and only the independent researcher will be aware of the coding of the syringes.

Inclusion criteria: Women aged 18 to 60 years with bilateral facial melasma, no use of topical or systemic melasma in the last 3 months. Exclusion criteria: Pregnancy and lactation, use of oral contraceptives, history of thrombotic diseases and coagulation disorders, Hypersensitivity to the study drugs or lidocaine, presence of active infectious lesions on the face.

Intervention Group 1 (Glutathione): Mesotherapy with glutathione 0.6% (Sina Darou), diluted with 2% lidocaine (10:1 ratio), intradermal injection using insulin syringe (30G needle), depth 1mm, volume 0.05ml, point spacing 1cm, 5 sessions every 2 weeks. Intervention Group 2 (Tranexamic Acid): Mesotherapy with tranexamic acid 4mg/ml (Aburayhan), diluted with 2% lidocaine (10:1 ratio), intradermal injection using insulin syringe (30G needle), depth 1mm, volume 0.05ml, point spacing 1cm, 5 sessions every 2 weeks. Care: Topical anesthetic cream (Xylapin) before injection and sunscreen SPF 50 after injection.

Melasma Area and Severity Index score

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.

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.