drugset / Trial / NCT07540702

Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma

NCT07540702

Recruiting 21 enrolled Kasr El Aini Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-02-01
Primary completion
2026-08-01
Completion
2026-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Injectable Platelet-Rich Fibrin Unknown Intravitreal
Comparator Tranexamic Acid Small molecule 10 mg/ml Intrathecal