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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Injectable Platelet-Rich Fibrin
Biological/VaccineInjectable 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.
Tranexamic acid 100 mg/mL (Kapron)
DrugTranexamic 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.
Treatment groups
21 Participants
are divided into 2 treatment groupsGroup A: Injectable Platelet-Rich Fibrin SideExperimental treatment 1 intervention
Group B: Intradermal Tranexamic Acid SideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change in Modified Melasma Area and Severity Index (mMASI) Score
The percent change in modified Melasma Area and Severity Index (mMASI) score from baseline to Day 90 will be assessed and compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
Time frame
Baseline and Day 90Secondary outcomes
1
Change in Melanin Level Measured by Antera 3D Camera
Change in average melanin level from baseline to Day 90, as measured by Antera 3D camera, will be assessed and compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
Time frame
Baseline and Day 902
Change in Vascular Features Measured by Antera 3D Camera
Change in vascular features, including hemoglobin/erythema index, from baseline to Day 90, as measured by Antera 3D camera, will be assessed and compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
Time frame
Baseline and Day 903
Physician Global Assessment of Improvement
Improvement in melasma at Day 90 will be assessed using Physician Global Assessment (PGA) based on standardized global photographs reviewed by 2 blinded dermatologists. Improvement will be categorized as excellent (\>75%), marked (50% to 75%), good (25% to 49%), fair (\<25%), or no response.
Time frame
Day 904
Change in Melasma Quality of Life (MelasQoL) Score
Change in Melasma Quality of Life (MelasQoL) score from baseline to Day 90 will be assessed and compared between treatment conditions in participants with facial melasma.
Time frame
Baseline and Day 90Sponsors and contacts
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Source ClinicalTrials.gov