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临床试验/NCT07263841
NCT07263841进行中(未招募)2 期

Comparison of Effectiveness of Tranexamic Acid Mesotherapy Versus Glutathione Mesotherapy in Post Burn Facial Hyperpigmentation

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
improvement in facial hyperpigmentation

研究概览

简要总结

INTERVENTION:

Patch test on forearm will be performed in all patients before starting treatment to check the sensitivity. Site of burn in the enrolled patients will include either cheek or forehead and total area (cm2) on each of above mentioned sites will be divided into two equal halves; one for tranexamic acid mesotherapy (maximum 5cm2) and other for glutathione mesotherapy (maximum 5cm2). Flip coin method will be used to decide which site and which half to be treated with tranexamic Acid or glutathione. Gentle cleansing of the affected area will be done Tranexamic acid is available in 500mg/5ml formulation, 1ml (100mg) of tranexamic acid will be taken and diluted in 10ml of 0.9% N/S i.e. 10mg/ml.This 10mg/ml of diluted formulation will be used for mesotherapy.

intradermally 1cm apart to the selected site using 1cc disposable syringe with 4mm depth 30G needle.4mm depth of intradermal injection will be controlled manually by the researcher on specific area of face. Maximum dose of tranexamic acid microinjections will not exceed 12.5 mg/5cm'.

Glutathione is available in 600mg powder formulation and will be prepared by dissolving in 5ml of distilled water. 1ml (120mg) of glutathione will be diluted in 10ml of 0.9% N/S i.e. 12mg/ml.This 12mg/ml of diluted formulation will be used for mesotherapy. Multiple microinjections, each 0.05ml (0.6mg) will be given intradermally 1cm apart to the selected site using 1cc disposable syringe with 4mm depth 30G needle. Maximum dose will not exceed 15mg/5cm2. All patients will be kept under observation for 20-30 minutes after each session to address any side effects (bruising, bleeding, pain etc.) and they will be advised to apply sunscreen of SPF 50 on whole of the face before sun exposure. After initial treatment session, patients will undergo six more treatment sessions with the same protocol at the interval of 2 weeks ( 2, 4, 6, 8, 10,12 weeks) and follow-up will be done monthly after the last session i.e. 4th, 5th and 6th month.

Final assessment will be done at 6th month. All clinical dermatoscopic photographs will be taken with Nikon D810 digital camera with dermlite 3 dermoscopy lens before the start of treatment, at each treatment session and then at each follow-up in same pre-settings, light and from same distance.

详细描述

Burn injuries are one of the leading cause of morbidity and mortality especially in developing countries. skin pigmentation disorders are one of the most frequent sequelae after burn injury while these conditions often improve over time,some are permanent and cause severe psychological disorders(specially on the face). 1 Inflammation of burnt skin triggers the melanocytes during the healing process which results in overproduction of melanin pigment that subsequently either gets dispersed to the epidermal keratinocytes or gets engulfed by the newly recruited macrophages leading to epidermal and dermal melanosis respectively. Unfortunately skin types with darker complexion due to melanosis (Fitzpatrick type III to IV), common in the subcontinent, are more susceptible to post inflammatory hyperpigmentation.1,2 A myriad of treatments including topical bleaching agents, chemical peels, tretinoins, sunscreens and various lasers have been used to prevent and reduce the hyperpigmentation with suboptimal results.

Tranexamic acid (TXA) is a novel agent used in the treatment of post burn hyperpigmentation, available in topical, oral and parentral formulations.3,4 The drug is widely used as anti-fibrinolytic agent and exerts its effects by inhibiting plasminogen-keratinocyte interaction leading to decrease in activity of tyrosinase enzyme thereby resulting in decrease synthesis of melanin from melanocytes.3,4 Human keratinocytes secrete plasminogen activator, which increases the plasmin production and melanogenesis.5 Blockade of this effect is the mechanism behind the therapeutic effect of tranexamic acid.6,7 Tranexamic acid mesotherapy can be a very good option for treating patients of post burn hyperpigmentation.

Glutathione (GSH) is widely used drug available in topical, oral and parenteral formulations with indications encompassing hyperpigmentation, anti-aging and antioxidant effects.8 It improves skin pigmentation by shifting melanogenesis from eumelanin (black brown in color) to pheomelanin (yellow red in color) through inhibiting tyrosinase enzyme, thus regulating the rate limiting step in melanin production.8,9 Glutathione is present intracellularly more abundantly in the reduced form (GSH) and is readily converted into its oxidized form (GSSG) in the process of scavenging free oxygen redicals and other toxins while trying to maintain the redox balance of cellular environment, as described by Sidarth sonthalia in his study. 9 Consequently the levels of glutathione are found to be decreased in the tissues experiencing metabolic stress due to various inflammatory processes like burns and other diseases i.e allergies, melasma and malignancies. 8,9 In our study, we will use mesotherapy, which is an effective way of delivering de-pigmentation drugs like tranexamic acid and glutathione directly into the dermis which is the nidus of ongoing inflammatory process in the burn wounds while avoiding the undesirable consequences of systemic therapy.7,10 There is limited data about the regimen protocol and quantitative comparison of these two types of mesotherapies. This will be the first study on local and international level for measurement of post burn facial hyperpigmentation as to date there are no reliable objective methods for measuring skin hyperpigmentation quantitatively in this population of patients. Our study, with availability of ideal population sample from one of the largest burn centre in the country, will surely add to scarce knowledge currently published in literature regarding the use of tranexamic acid and glutathione to overcome hyperpigmentation. This can lower the psychosocial stigmata of post burn marks and ease the way of burn survivors for re-integration into society.

6.4 OBJECTIVE:

To compare the quantitative effectiveness of tranexamic acid mesotherapy versus glutathione mesotherapy in post burn facial hyperpigmentation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

outcome assessor will be masked to overcome biasness

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ● Both sexes of WHO adult age group 18-65 years .
  • Patients with healed facial burns managed conservatively without skin grafting.
  • From 6 month to 12 month post burn injury (patient enrollment to be done before scar maturation starts)
  • Patients with Fitzpatrick skin types III to IV.
  • Patients with mental capacity to give informed consent.

排除标准

  • ● Patients with documented hypersensitivity reactions to either drug or dressing etc.
  • History of de-pigmentation treatment, phototherapy.
  • Healed burn wounds with hypertrophic scar.
  • History of bleeding or clotting disorders, renal disease, collagen vascular disease and other photodermatoses
  • Pregnant or lactating females
  • Patients on hormone replacement therapy, oral contraceptives, concomitant use of anticoagulant, or any photosensitizing drug3.

研究组 & 干预措施

fitzpatrick skin type3,4 patients of post burn facial hyperpigmentation will be included in this arm

Experimental

facial hyperpigmentation lesion will be divided into 2 halves and one treatment will be administered on each half

干预措施: Tranexamic Acid (Drug)

结局指标

主要结局

improvement in facial hyperpigmentation

时间窗: 6months

patients will be assessed for improvement in hyperpigmentation by skin hyperpigmentation index till 6 months after completion of sessions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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