Actively Recruiting
Assessment of Efficacy and Safety of Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid in the Treatment of Melasma: A Randomized Split-Face Study
Led by Kasr El Aini Hospital · Updated on 2026-04-22
21
Participants Needed
1
Research Sites
8 weeks
Total Duration
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AI-Summary
What this Trial Is About
Melasma is a common chronic skin condition causing brown to gray-brown patches, primarily on the face, especially in adult women with certain skin types. This research compares two treatments for facial melasma: injectable platelet-rich fibrin (i-PRF), a platelet concentrate from the patient's own blood, and intradermal tranexamic acid (TA), a drug that may reduce pigmentation. The study aims to assess which treatment is safer and more effective for improving melasma. Adult female patients with mild to moderate symmetrical facial melasma will participate. Each participant's face will be split: one side will receive i-PRF injections prepared from their blood, and the other side will receive intradermal tranexamic acid injections. Both treatments will be given in five sessions spaced two weeks apart, alongside instructions to use sunscreen and avoid other facial treatments. Participants will be evaluated before treatment and 90 days later using various measures such as the modified Melasma Area and Severity Index (mMASI), skin imaging with the Antera 3D camera, physician assessments, patient satisfaction, and quality of life questionnaires. Safety will be monitored by recording any side effects like pain, redness, swelling, or bruising. This study is designed to provide detailed comparisons of efficacy and safety between these two treatments.
CONDITIONS
Brief Title
Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 10 weeks
Participants receive five treatment sessions at 2-week intervals. One side of the face is treated with injectable platelet-rich fibrin (i-PRF) prepared from their own blood, while the other side receives intradermal tranexamic acid injections. Participants are instructed to use broad-spectrum sunscreen and avoid other facial treatments during this period.
5 treatment sessions at 2-week intervals
Duration - Up to Day 90 from baseline
Participants are assessed at the end of the study to evaluate treatment effects and safety, including changes in pigmentation, vascular features, and quality of life, as well as any adverse events.
1 visit at Day 90
Trial Site Locations
Total: 1 location
1
Kasr El Aini Hospital
Cairo, Cairo Governorate, Egypt, 11555
Actively Recruiting
Research Team
H
Heba Ahmed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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