About this trial
Melasma is a chronic acquired hyperpigmentation disorder that commonly affects the face and has a significant impact on quality of life. Available treatments may improve pigmentation, but relapse is common and response can be variable.
This randomized split-face interventional study aims to compare the efficacy and safety of injectable platelet-rich fibrin (i-PRF) versus intradermal tranexamic acid (TA) in the treatment of facial melasma. Adult female patients with bilateral symmetrical facial melasma will be enrolled. In each participant, one side of the face will be randomly assigned to receive i-PRF and the contralateral side will receive intradermal TA.
Patients will undergo five treatment sessions at 2-week intervals. Clinical response will be assessed using the modified Melasma Area and Severity Index (mMASI), Antera 3D camera measurements, Physician Global Assessment, patient satisfaction, and Melasma Quality of Life (MelasQoL) questionnaire. Safety will be evaluated by recording adverse events such as pain, tenderness, erythema, swelling, infection, ecchymosis, and hematoma.
The study is designed to determine whether i-PRF is an effective and safe treatment option for melasma compared with intradermal tranexamic acid.
Eligibility criteria
Qualifiers
Clinical diagnosis of bilateral symmetrical facial melasma (epidermal or mixed type)
Female participants aged 18 to 50 years
Fitzpatrick skin types III to IV
Mild to moderate facial melasma
Disqualifiers
Pregnancy or lactation
Bleeding or coagulation disorders
Use of anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs), or hormonal contraception
Active skin infection or facial inflammation
Trial design
Treatments tested in this trial
- Injectable Platelet-Rich Fibrin
- Tranexamic acid 100 mg/mL (Kapron)