Injectable platelet-rich fibrin versus intradermal tranexamic acid for facial 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
This compares injections of a patient's own platelet-rich fibrin with tiny intradermal tranexamic acid shots to see which reduces facial melasma better in adult women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07540702 on ClinicalTrials.gov |
What this trial studies
This randomized split-face trial enrolls adult women with bilateral symmetrical facial melasma and treats one side with injectable platelet-rich fibrin (i-PRF) and the other side with intradermal tranexamic acid. Participants receive five treatment sessions at two-week intervals with within-subject comparison to reduce variability. Outcomes include mMASI scoring, Antera 3D imaging, Physician Global Assessment, patient satisfaction, and the Melasma Quality of Life questionnaire, with safety monitoring for local and systemic adverse events. The study is conducted at Kasr El Aini Hospital in Cairo.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–50 with bilateral symmetrical mild-to-moderate facial melasma and Fitzpatrick skin types III–IV who have not had recent melasma-specific treatments or facial procedures.
Not a fit: Patients who are pregnant or breastfeeding, have bleeding/coagulation disorders, use anticoagulants, NSAIDs, or hormonal contraception, have uncontrolled systemic disease, or have non-symmetrical or markedly different skin types may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could provide a more effective and longer-lasting option to reduce facial melasma and improve quality of life.
How similar studies have performed: Intradermal tranexamic acid has shown promising results in prior studies, while i-PRF has biological rationale but limited clinical evidence specifically for melasma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Cairo, Cairo Governorate
- Kasr El Aini Hospital — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Heba Ahmed
- Email: heba.a.abdelgayed@kasralainy.edu.eg
- Phone: +201016532351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.