Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for 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

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.

Study Overview

• Status: Recruiting
• Conditions: Melasma; Facial Melasma
• Intervention / Treatment: Biological: Injectable Platelet-Rich Fibrin; Drug: Tranexamic acid 100 mg/mL (Kapron)

Detailed Description

Melasma is a common chronic hyperpigmentation disorder characterized by symmetric brown to gray-brown patches, most commonly affecting the face. It is more frequent in women and in individuals with darker skin phototypes, and it may significantly impair psychosocial well-being and quality of life. Multiple pathogenic mechanisms have been implicated, including ultraviolet exposure, hormonal influences, genetic predisposition, melanocyte hyperactivity, and dermal vascular and inflammatory changes.

Current melasma therapies include topical depigmenting agents, chemical peels, laser and light-based procedures, and oral or local tranexamic acid. However, treatment response is often incomplete and recurrence is common. Intradermal tranexamic acid has shown promising results in reducing pigmentation through inhibition of plasmin activity and downstream melanocyte stimulation.

Injectable platelet-rich fibrin (i-PRF) is a second-generation autologous platelet concentrate prepared without anticoagulants. It provides a fibrin scaffold and gradual release of growth factors. Based on its biologic activity, i-PRF may have a therapeutic role in melasma by modulating melanogenesis, oxidative stress, and tissue repair. Despite this rationale, clinical evidence for i-PRF in melasma remains limited.

This study is a randomized split-face clinical trial designed to compare the efficacy and safety of i-PRF versus intradermal tranexamic acid in the treatment of facial melasma. Twenty-one adult female patients with mild to moderate bilateral symmetrical facial melasma, aged 18 to 50 years and with Fitzpatrick skin types III to IV, will be recruited from the outpatient dermatology clinic and cosmetology unit of Kasr El Ainy Hospital, Cairo University, Cairo, Egypt.

For each participant, one side of the face will be randomly assigned to receive i-PRF, while the contralateral side will receive intradermal tranexamic acid. Injectable platelet-rich fibrin (i-PRF) will be prepared from 10 mL of venous blood collected under aseptic conditions in a plain plastic tube and centrifuged at 60 g (700 rpm) for 3 minutes. The resulting i-PRF will be injected intradermally on the randomized side after topical anesthetic application. The opposite side will receive intradermal tranexamic acid prepared under aseptic conditions and injected at 1 cm intervals into melasma lesions. Participants will receive five treatment sessions at 2-week intervals. They will also be instructed to use broad-spectrum sunscreen and to avoid other topical facial treatments during the study period.

Both participants and outcome assessors will be blinded to the treatment allocation. Assessment will be performed at baseline and at the end of the study (Day 90). The primary outcome is the percent change in modified Melasma Area and Severity Index (mMASI) score from baseline to Day 90 between the i-PRF-treated side and the tranexamic-acid-treated side. Secondary outcomes include change in melanin level and vascular features measured by Antera 3D camera, Physician Global Assessment, patient satisfaction, global improvement scale, Melasma Quality of Life (MelasQoL) score, and adverse events.

Potential adverse effects include pain, tenderness, erythema, swelling, infection, ecchymosis, hematoma, and pigmentation changes. The study aims to determine whether i-PRF is an effective and safe therapeutic option for melasma compared with intradermal tranexamic acid.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Ahmed; Phone Number: +201016532351; Email: heba.a.abdelgayed@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11555
      • Recruiting
      • Kasr El Aini Hospital
      • Contact: Heba Ahmed, Lecturer of Dermatology; Phone Number: +201016532351; Email: drhebaahmedyt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injectable Platelet-Rich Fibrin Side; In this randomized split-face study, one side of each participant's face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF). i-PRF is prepared from autologous venous blood and injected intradermally on the assigned side after topical anesthetic. Participants receive 5 treatment sessions 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.
Active Comparator: Intradermal Tranexamic Acid Side; In this randomized split-face study, the contralateral side of each participant's face receives intradermal tranexamic acid after topical anesthetic. Tranexamic acid is prepared under aseptic conditions and injected intradermally into melasma lesions. Participants receive 5 treatment sessions at 2-week intervals.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Day 90
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.	Baseline and Day 90
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.	Day 90
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.	Baseline and Day 90
Incidence of Treatment-Emergent Adverse Events	Incidence of adverse events during the study period will be assessed, including pain, tenderness, erythema, swelling, infection, pigmentation changes, ecchymosis, and hematoma, and will be compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.	Up to Day 90
Patient Satisfaction at Day 90	Participant satisfaction with treatment outcome at Day 90 will be assessed and categorized as highly satisfied, moderately satisfied, partially satisfied, or not satisfied.	Day 90

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Melasma; Tranexamic acid; i-PRF; Injectable platelet-rich fibrin; Split-face study
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Skin and Connective Tissue Diseases; Melanosis; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: MS-654-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No