Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma; a Split Face Study in Tertiary Care Hospital of Karachi
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in HEMI-Modified Melasma Area and Severity Index (mMASI)
研究概览
简要总结
It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.
详细描述
In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value < 0.01 was taken significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant do not know about the split face study. Their one side was injected by tranexamic acid diluted in normal saline while other side was injected with simple normal saline.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •age between 18 to 55 years
- •bilateral symmetrical mild to severe melasma
排除标准
- •pregnancy and lactation
- •history of taken any topical treatment for melasma in previous 1 month
- •history of bleeding disorders
- •concomitant use of anticoagulants,
- •any known drug allergy especially to the study drug,
- •having associated medical illnesses.
研究组 & 干预措施
Tranexamic acid
Left side of face of each participant was selected for intradermal Tranexamic acid injections.
generic name : Tranexamic acid Dose : 4mg / ml tranexamc acid diluted with 0.9 % normal saline Frequency : every 2 weekly total 6 doses. Duration : 6 months
干预措施: Tranexamic Acid (Drug)
Tranexamic acid
Left side of face of each participant was selected for intradermal Tranexamic acid injections.
generic name : Tranexamic acid Dose : 4mg / ml tranexamc acid diluted with 0.9 % normal saline Frequency : every 2 weekly total 6 doses. Duration : 6 months
干预措施: 0.9% Normal Saline (Drug)
0.9% Normal saline
Right side of face of each participant was selected for intradermal normal saline injections generic name : Normal Saline Dose : 0.9 % Normal Saline Dose : Frequency : every 2 weekly total 6 doses. Duration : 6 months
干预措施: 0.9% Normal Saline (Drug)
结局指标
主要结局
Change in HEMI-Modified Melasma Area and Severity Index (mMASI)
时间窗: 10 months
Calculation of Hemi mMASI score is performed by rating darkness and area of involvement of 3 areas of the each half of face. These figures are then inserted into an equation, resulting in the final Hemi mMASI score for both halves of face. Equation : forehead (0.15×D×A) + malar ( 0.30×D×A) + chin ( 0.05×D×A) The mean value of the data obtained from each half of the face was calculated and the mean percentage change was compared. Hemi-MASI score was used because of the study design of split-face, and it was calculated based on the percentage of the involved area Improvement was considered when there was reduction in mean hemi modified MASI score at both sides of face. Higher score was considered as worse and low score was considered as good in improvement of melasma. At each follow-up visit, adverse events were also evaluated. Patients were asked to reports side effects such as erythema, burning, swelling, and change in menstrual cycle during and after treatment.
次要结局
未报告次要终点
研究者
Dr Sana Kaleem
Department of Dermatology, SKaleem, FCPS II Postgraduate Trainee
Jinnah Postgraduate Medical Centre