CTRI/2024/04/065382尚未招募4 期
A comparative study to evaluate the efficacy and safety of oral tranexamic acid with triple combination cream versus triple combination cream monotherapy in the treatment of Melasma
MOHAN H N1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年4月18日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in melasma area and severity index
研究概览
简要总结
Oral tranexamic acid is proved as a promising treatment option for melasma because of its demonstrated efficacy and limited side effect profile as a monotherapy and in combination with other modalities. Very few trials have been done regarding efficacy of oral tranexamic acid in Indian setting. so this study aims at comparing efficacy of combining oral tranexamic acid with triple combination cream versus triple combination cream alone in management of melasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give informed consent
- •Patients of either gender aged more than 18 years
- •Patients willing for follow up
- •Patients with clinically diagnosed melasma.
排除标准
- •Patient not willing to give informed consent
- •Patient already on melasma treatment with topical therapy within 2 weeks.
- •Pregnant and lactating females.
- •History of coexisting endocrinopathies.
- •History of thrombosis, thromboembolic episodes and altered blood coagulation profile.
结局指标
主要结局
Change in melasma area and severity index
时间窗: Change in melasma area and severity index at 4 weeks and 8 weeks
次要结局
- Safety and tolerability parameters of study medications(At 4 weeks and 8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Oral and Topical Tranexamic Acid for the Treatment of MelasmaChloasmaMelasmaMelanosisNCT03585179Centro Dermatológico Dr. Ladislao de la Pascua120
Unknown
4 期
Oral Tranexamic Acid and Laser for Treatment of MelasmaMelasmaNCT03686787Laser and Skin Surgery Center of New York32
已完成
不适用
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - VMelasmaNCT05236569Indonesia University34
尚未招募
4 期
Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis ManagementEpistaxis NosebleedNCT06490653Ankara Ataturk Sanatorium Training and Research Hospital186
已完成
3 期
Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee SurgeryOsteoarthritis, KneeNCT03386656Fundación Pública Andaluza Progreso y Salud150