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临床试验/NCT07540702
NCT07540702招募中不适用

Assessment of Efficacy and Safety of Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid in the Treatment of Melasma: A Randomized Split-Face Study

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
21
试验地点
1
主要终点
Percent Change in Modified Melasma Area and Severity Index (mMASI) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Tranexamic acid 100 mg/mL (Kapron) (Drug)

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.

干预措施: Injectable Platelet-Rich Fibrin (Biological)

结局指标

主要结局

Percent Change in Modified Melasma Area and Severity Index (mMASI) Score

时间窗: Baseline and Day 90

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.

次要结局

  • Patient Satisfaction at Day 90(Day 90)
  • 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)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

heba ahmed abdelgayed ibrahim

Lecturer of Dermatology

Kasr El Aini Hospital

研究点 (1)

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