Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorKasr El Aini Hospital

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)

Treatment groups

21 Participants
are divided into 2 treatment groups

Sponsors and collaborators