Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma

NCT07540702 | Recruiting

• 1 other identifier: MS-654-2025
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma; Facial Melasma

Keywords

Injectable platelet-rich fibrin; i-PRF; Tranexamic acid; Melasma; Split-face study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Melanin Level Measured by Antera 3D Camera

  Baseline and Day 90

• Change in Vascular Features Measured by Antera 3D Camera

  Baseline and Day 90

• Physician Global Assessment of Improvement

  Day 90

• Change in Melasma Quality of Life (MelasQoL) Score

  Baseline and Day 90

• Incidence of Treatment-Emergent Adverse Events

  Up to Day 90

Study Arms (2)

Injectable Platelet-Rich Fibrin Side

EXPERIMENTAL

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

Intradermal Tranexamic Acid Side

ACTIVE COMPARATOR

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)

Interventions

Injectable Platelet-Rich Fibrin BIOLOGICAL

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.

Injectable Platelet-Rich Fibrin Side

Tranexamic acid 100 mg/mL (Kapron) DRUG

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.

Intradermal Tranexamic Acid Side

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, Cairo Governorate, 11555, Egypt

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Heba Ahmed

CONTACT

+201016532351; heba.a.abdelgayed@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are blinded to treatment allocation. Global photographs and clinical outcomes are assessed by blinded dermatologists. The treating provider administering the injections is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Model Details: This is a randomized split-face, within-participant controlled trial. In each participant, one side of the face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF) and the contralateral side is assigned to receive intradermal tranexamic acid. Both interventions are administered during the same study period.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)