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Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma

NCT07540702 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Melasma
  • Facial Melasma

Interventions

DRUG

Tranexamic acid 100 mg/mL (Kapron)

Tranexamic 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.

BIOLOGICAL

Injectable Platelet-Rich Fibrin

Injectable 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.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07540702 on ClinicalTrials.gov