NCT07540702 Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma
| NCT ID | NCT07540702 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kasr El Aini Hospital |
| Condition | Melasma |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 21 participants in total. It began in 2026-02-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07540702 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Melasma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07540702 currently recruiting?
Yes, NCT07540702 is actively recruiting participants. Contact the research team at heba.a.abdelgayed@kasralainy.edu.eg for enrollment information.
Where is the NCT07540702 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07540702 clinical trial?
NCT07540702 is sponsored by Kasr El Aini Hospital. The trial plans to enroll 21 participants.