Comparative Efficacy of Intralesional Tranexamic Acid Versus Mandelic Acid Peel in the Treatment of Melasma
2026年5月24日 更新者：Dr Shapara Shakeel、Combined Military Hospital Abbottabad
Melasma is a chronic acquired disorder of facial hyperpigmentation that significantly affects quality of life.
Both intralesional tranexamic acid and mandelic acid chemical peels are effective treatment options with favorable safety profiles in darker skin types.
However, comparative evidence in South Asian populations is limited.
This study aims to compare the efficacy, safety, quality of life outcomes, and patient satisfaction of intralesional tranexamic acid versus mandelic acid peel in patients with facial melasma treated at Combined Military Hospital Abbottabad.
研究概览
详细说明
This quasi-experimental, non-randomized controlled trial will be conducted in the Department of Dermatology, Combined Military Hospital Abbottabad.
A total of 120 patients aged 18-45 years with clinically diagnosed facial melasma will be enrolled and allocated alternately into two groups.
Group A will receive mandelic acid chemical peels every two weeks for six sessions.
Group B will receive intradermal tranexamic acid injections every two weeks for six sessions.
All participants will receive sunscreen and photoprotection counseling.
Outcomes will be assessed using Physician Global Assessment, modified Melasma Area and Severity Index (mMASI), MELASQoL questionnaire, adverse event monitoring, and patient satisfaction over a 12-week period.
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shapara Shakeel, MBBS, FCPS-resident derm
- 电话号码：+923489081830
- 邮箱：shaparashakil@gmail.com
研究联系人备份
- 姓名：Ovais Faizi, MBBS, FCPS(Internal Medicine)
- 电话号码：+923134422922
- 邮箱：ovaisfaizi@yahoo.com
学习地点
-
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KPK
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Abbottabad、KPK、巴基斯坦、22010
- Combined Military Hospital, Abbottabad
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接触：
- Ali Amar, MBBS, FCPS(Dermatology), CHPE
- 电话号码：+923215625426
- 邮箱：docaliamar@gmail.com
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接触：
-
首席研究员：
- Shapara Shakeel, MBBS, FCPS-resident derm
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
Age 18-45 years. Clinical diagnosis of facial melasma. Fitzpatrick skin phototypes III-V. Disease duration of at least 3 months.
Exclusion Criteria:
Pregnancy or lactation. Known hypersensitivity to tranexamic acid or mandelic acid. Active facial dermatoses or infection. Personal or family history of thromboembolic disease. Coagulation disorders. Systemic retinoid use within 6 months. Oral contraceptive or hormone replacement therapy within 6 months. Use of topical or systemic depigmenting agents within 4 weeks. History of keloid tendency.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Mandelic Acid Peel
Participants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks.
|
After degreasing the face, mandelic acid solution will be applied for 5-7 minutes and then neutralized.
Sessions will be repeated every two weeks for six sessions.
|
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有源比较器：Intralesional Tranexamic Acid
Participants will receive intradermal tranexamic acid injections every two weeks for six sessions over 12 weeks.
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Tranexamic acid will be injected intradermally at 1-cm intervals over melasma patches using a 30-gauge insulin syringe every two weeks for six sessions.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants achieving a Physician Global Assessment rating of good or excellent.
大体时间：12 weeks
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Good response is defined as ≥51% improvement and excellent response as ≥76% improvement in pigmentation.
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12 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Frequency of treatment-related adverse events
大体时间：Throughout the 12-week treatment period
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Throughout the 12-week treatment period
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Change in modified Melasma Area and Severity Index(0-24), 0-clear, 24-severe
大体时间：Baseline to 12 weeks
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Baseline to 12 weeks
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Change in Melasma Quality of Life Scale MELASQoL score(7-70) 10 - 39: Mild quality of life impairment, 40 - 54: Moderate quality of life impairment, 55 - 70: Severe quality of life impairment .
大体时间：Baseline to 12 weeks
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Baseline to 12 weeks
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Patient satisfaction score (Likert Scale 1-5, 1:Very Dissatisfied, 5: Satisfied)
大体时间：12 weeks
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12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Ali Amar, MBBS, FCPS(dermatology), CHPE、Combined Military Hospital Abbottabad
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19.
- Xu L, Ding X, Ying L, Zhang X, Lu N. Follicular Lymphoma Presenting With Monoclonal IgM And MYD88 Mutation: A Case Report And Review Of The Literature. Onco Targets Ther. 2019 Sep 23;12:7833-7842. doi: 10.2147/OTT.S211436. eCollection 2019.
- Tong M, Kotur T, Liang W, Vogelmann K, Kleine T, Leister D, Brieske C, Yang S, Ludke D, Wiermer M, Zhang Y, Li X, Hoth S. E3 ligase SAUL1 serves as a positive regulator of PAMP-triggered immunity and its homeostasis is monitored by immune receptor SOC3. New Phytol. 2017 Sep;215(4):1516-1532. doi: 10.1111/nph.14678. Epub 2017 Jul 10.
- Ikino JK, Nunes DH, Silva VP, Frode TS, Sens MM. Melasma and assessment of the quality of life in Brazilian women. An Bras Dermatol. 2015 Mar-Apr;90(2):196-200. doi: 10.1590/abd1806-4841.20152771.
- Slovacek L, Slovackova B, Slanska I, Hrstka Z, Priester P. Incidence and relevance of depression among palliative care female inpatients. Eur J Cancer Care (Engl). 2010 Sep;19(5):e8-9. doi: 10.1111/j.1365-2354.2008.01030.x. Epub 2009 Aug 25. No abstract available.
- Sedighi M, Haghnegahdar A. Lumbar disk herniation surgery: outcome and predictors. Global Spine J. 2014 Dec;4(4):233-44. doi: 10.1055/s-0034-1390010. Epub 2014 Sep 26.
- Marsidi N, Beijnen JH, van Zuuren EJ. Palladium-induced granulomas analysed with inductively coupled plasma mass spectrometry. Contact Dermatitis. 2018 Jul;79(1):41-42. doi: 10.1111/cod.12979. Epub 2018 Mar 1. No abstract available.
- Nagalakshmi S, Sriram G, Balachandar K, Dhayanithi D. A comparative evaluation of mandibular incisor decrowding with coaxial and optiflex arch wires and their load-deflection rates. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S118-21. doi: 10.4103/0975-7406.137412.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月1日
初级完成 (估计的)
2026年8月1日
研究完成 (估计的)
2026年10月1日
研究注册日期
首次提交
2026年5月17日
首先提交符合 QC 标准的
2026年5月17日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月24日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- CMH-Atd-ETH-242-Derma-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be made publicly available.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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