A prospective, randomised study comparing the therapeutic efficacy and safety of topical, oral and localised intradermal microinjections of tranexamic acid in patients with facial melasma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Compare efficacy of therapy with respect to decrease in size and hyperpigmentation of lesion
研究概览
简要总结
Melasma is an acquired facial hypermelanosis that presents as light to dark brown macules and patches most commonly seen over sun exposed areas of face and neck. The chronic recurring nature of the disease, incomplete understanding of disease pathogenesis and unstable patient response to treatment provide a unique challenge to the treating physician. The cosmetic disfigurement caused can be socially distressing affecting patient quality of life.
Various treatment options include topical and oral medicaltions, procedures, chemical peels, Lasers and combination therapy. Tranexamic Acid has emerged as an effective treatment option finding use in topical, oral and intradermal preparations.
This randomized, prospective study aims to compare efficacy and safety of topical, oral and intradermal Tranexaic acid in the treatment of facial melasma. Study will be conducted in a tertiary care set up. Patients enrolled will be divided into 3 groups. Group A will receive topical tranexamic acid. Group B will receive oral tranexamic acid and Group C will be treated using intradermal injections of tranexamic acid. Treatment duration is months with a follow up period of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients diagnosed with facial melasma.
排除标准
- •Children < 18 years of age, pregnant or nursing women or women planning pregnancy during the duration of trial. Patients with Extra.
- •facial melasma Patient unwilling to give consent to be part of trial. Current use of oral or injectable contraceptives, hormone replacement therapy, blood thinning medications, photosensitizing drugs or drugs known to cause hyperpigmentation of skin. Current or previous use of any medical treatment (topical or oral) or cosmetic procedure (chemical peel, Laser, Dermabrasion) for melasma within 9 months of study enrollment. History of thromboembolic disease such as deep vein thrombosis (DVT), >2 spontaneous abortions, pulmonary embolism or cerebral thrombosis, stroke or subarachnoid haemorrhage. Family history of thromboembolic disease. Smoking, tobacco use. Hypersensitivity to tranexamic acid or sunscreen ingredients. Abnormal bleeding profile (PT INR, Bleeding Time, Clotting Time).
结局指标
主要结局
Compare efficacy of therapy with respect to decrease in size and hyperpigmentation of lesion
时间窗: Calculation of modified Melasma Severity Index. | Assessment of clinical photographs by blinded physicians by percentage response scale. | Patient satisfaction measured according to 5 point Liker Scale. | Measured at baseline,4 weeks, 8 weeks, 12 weeks and 3 months post treatment
次要结局
- Analyze the safety and tolerability of different preparations of tranexamic acid with respect to adverse effects related to therapy(Compared during course of therapy, at end of therapy and end of post treatment follow up period.)