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临床试验/CTRI/2025/08/092525
CTRI/2025/08/092525尚未招募Phase 3 4

Intradermal Tranexamic Acid Vs Intradermal Platelet-Rich Plasma In The Treatment Of Melasma- A Randomised Control Study

Krishna Mohan Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月29日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Pain

研究概览

简要总结

Melasma is a common, multifactorial hyperpigmentation disorder that negatively impacts quality of life. While many topical and procedural treatments exist for this condition, a definitive therapy remains elusive. The study focuses on two modern intradermal therapies Tranexamic Acid (TXA), which inhibits UV induced plasmin activity in keratinocytes, and Platelet Rich Plasma (PRP), which uses growth factors like TGF beta1 to inhibit melanin synthesis. The existing literature provides conflicting results from previous studies comparing these two modalities, thereby establishing the need for further research. The primary aim of the study is to compare the efficacy of intradermal TXA versus intradermal PRP in the treatment of melasma. The objectives are to evaluate the effectiveness of each treatment individually and then to compare the outcomes of the two treatment arms. This will be a randomized prospective interventional study. We will enroll 40 patients who will be randomized into two groups of 20 each. Group A will receive intradermal injections of TXA. Group B will receive intradermal injections of autologous PRP. The treatment will consist of a maximum of four sessions administered at four weekly intervals for both groups. Patients aged 18 to 50 years are eligible for inclusion , while those who are pregnant, breastfeeding, on oral contraceptives, or have bleeding disorders are among those who will be excluded. The primary outcome will be the evaluation of efficacy via the modified Melasma Area and Severity Index (mMASI) score. Written informed consent will be obtained from all participants.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • ADULT PATIENTS WITH EPIDERMAL OR DERMAL OR MIXED MELASMA.

排除标准

  • Patients who have used any form of melasma treatment, whether oral or topical, within the previous 3 months.
  • Patients with established platelet dysfunction disorder.
  • Patients on oral contraceptive pills.
  • Known cases of bleeding disorders.
  • Pregnant women.
  • Breastfeeding females.
  • Patients on anticoagulants.

结局指标

主要结局

Pain

时间窗: 1, 2, 3, 4, 7 MONTHS

Erythema

时间窗: 1, 2, 3, 4, 7 MONTHS

Inflammation

时间窗: 1, 2, 3, 4, 7 MONTHS

次要结局

  • Hypopigmentation(Recurrence)

研究者

发起方
Krishna Mohan Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Simran Jain

Krishna Mohan Medical College and Hospital

研究点 (1)

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