RecruitingNot ApplicableNCT07540702

Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma

Assessment of Efficacy and Safety of Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid in the Treatment of Melasma: A Randomized Split-Face Study

Sponsor

Kasr El Aini Hospital

Enrollment

21 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Melasma Facial Melasma

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria7

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
No melasma-specific treatment within the previous 4 weeks
No facial procedures, including peeling, laser resurfacing, or microneedling, within the previous 3 months
Willing and able to provide written informed consent and comply with study procedures

Exclusion Criteria6

Pregnancy or lactation
Bleeding or coagulation disorders
Use of anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs), or hormonal contraception
Active skin infection or facial inflammation
History of keloids or Koebner-prone conditions, such as psoriasis or vitiligo
Uncontrolled systemic disease, such as diabetes mellitus or autoimmune disease

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Interventions

BIOLOGICALInjectable Platelet-Rich Fibrin

Injectable platelet-rich fibrin (i-PRF) is prepared from 10 mL of autologous venous blood collected in a plain plastic tube without additives and centrifuged at 60 g (700 rpm) for 3 minutes. The resulting fluid is aspirated immediately and injected intradermally on the randomized side of the face at a dose of 0.1 mL/cm² at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals.

DRUGTranexamic acid 100 mg/mL (Kapron)

Tranexamic acid (Kapron ampoules, 100 mg/mL) is diluted under aseptic conditions to a final concentration of 10 mg/mL by adding 0.1 mL of tranexamic acid to normal saline to a total volume of 1 mL. After topical anesthetic application, approximately 1 mL of the prepared 10 mg/mL solution is injected intradermally into melasma lesions on the contralateral side of the face at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals.