A comparative study to evaluate the efficacy of intralesional tranexamic acid versus intralesional platelet rich plasma in the treatment of melasma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To compare the efficacy of intralesional Tranexamic acid versus intralesional Inj platelet rich plasma in the treatment of melasma.
研究概览
简要总结
Melasma affects the psychological, emotional, and social well-being of a person, impacting their quality of life.
The current treatment modalities are associated with their own disadvantages.Hence, there is a need for newer modalities of treatment
This study will be conducted on allconsenting male and female patients with melasma.A study population consisting of 44 satisfying the inclusion and exclusion criteria will be recruited. With the informed consent obtained from the patients, a detailed history and examination will be done with the help of a predesigned proforma. Melasma will be diagnosed by history and clinical features. Baseline evaluation was made at the first visit, and the demographic data were recorded in a structured questionnaire designed for this study.
Before treatment and at each follow-up appointment, clinical pictures were taken.Clinical photographs were taken at each visit and reduction in Modified Melasma Area and Severity Index (mMASI) was assessed at each visit. Response was graded as:
-
No response
-
Partial or fair response (0%-25% reduction)
-
Good response (26%-50% reduction)
-
Very good response (51%-75% reduction)
-
Excellent (>75% reduction)
All patients fulfilling the inclusion criteria were categorized into two groups depending on the treatment they received, namely, Group A (intralesional tranexamic acid) and Group B (platelet rich plasma) (n=22 per group )
Both Inj tranexamic acid and PRP are available at the institution.
Group A : Two units of TXA was drawn in a 40 U/ml 30 G insulin syringe and diluted with normal saline upto 1 ml (remaining 38 U out of total40 U) in order to obtain a concentration of 4 mg/ml of TXA. The face was numbed with ice packs that were kept for a period of 5–10 min, followed by cleansing with alcohol swabs, after which intradermal injections of TXA was administered over the hyper-pigmented patches, separating each prick with a 1 cm distance.Based on the area of involvement injections were given, the total dose not exceeding 16 mg of intradermal TXA. Five such sessions were administered at intervals of 4 weeks and advice regarding stringent photoprotection stated. All patients were prescribed sunscreen with for the entire duration of treatment.
Group B :The antecubital fossa of each patient was cleansed with an alcohol swab following which 10 ml of venous blood was withdrawn from that region. The blood was centrifuged to obtain PRP. We obtained approximately 1–1.2 ml of PRP from 10 ml of whole blood. This was immediately injected into the melasma areas at 1 cm interval, following numbing and cleansing of the face as described for TXA.
In each group clinical photographs were taken at baseline and at every 4 weeks (0, 4, 8, 12, 16, and 20 weeks) until the end of the study period for evaluation of therapeutic outcome and adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Either gender 2) Age range of 20 to 50 years 3)Patients suffering from melasma.
- •Patients who didn’t respond to conventional topical therapy for melasma.
排除标准
- •Pregnancy and lactation 2)patients with known platelet dysfunction 3)Those with prior history of allergy to tranexamic acid (may june) 4)Intake of any photosensitizing drugs 5) Known allergy to TXA.
- •Women on oral contraceptive pills and hormone replacement therapy.
- •Patients on any topical therapy for melasma in the past 3 months.
- •Critical thrombocytopenia less than 50,000/mcl.
- •Any history of hemodynamic instability.
结局指标
主要结局
To compare the efficacy of intralesional Tranexamic acid versus intralesional Inj platelet rich plasma in the treatment of melasma.
时间窗: 20 weeks
次要结局
未报告次要终点
研究者
Ashrita Krishna
Hassan Institute Of Medical Sciences
