CTRI/2015/04/005697已完成Unknown
An Open Label, Single Arm, Observational Study to Evaluate Efficacy, Safety and Tolerability of 4-n-butylresorcinol in Patients with Melasm
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of 4-n-butylresorcinol in reducing melasma
研究概览
简要总结
This study is Open Label,Single Arm, Observational Study to Evaluate Efficacy, Safety and Tolerabilityof 4-n-butylresorcinol in 50 subjects with Melasma. The study conducted at two sites inIndia. The primary outcome measures efficacy of 4-n-butylresorcinol in reducingmelasma and the secondary outcome measures safety and tolerability of 4-n-butylresorcinol bythe investigators. The total treatment period is 8 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects with melasma who are either treatment naive or were not on any treatment for at-least 6 months •Subjects aged 18 and above years with melasma •Subjects with Epidermal type of melasma •Subjects with Fitzpatrick skin types III, IV and V •Subjects willing to apply sunscreen during the course of study •Subjects willing to return for all clinic visits and complete all study-related procedures.
排除标准
- 未提供
结局指标
主要结局
Evaluate the efficacy of 4-n-butylresorcinol in reducing melasma
时间窗: 4th week and 8th Week
次要结局
- Evaluate safety of 4-n-butylresorcinol based on the adverse effects as mentioned by the patient and evaluated by the investigator.(Assess tolerability of 4-n-butylresorcinol by the investigators)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
Unknown
Safety and efficacy of Ketoconazole in Combination With BeclomethasoneCTRI/2018/02/011935Med Manor Organics Pvt ltd50
Unknown
1 期
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05122572Wuxi People's Hospital36
已完成
2/3 期
Clinical study of Hair Oil formulation in Hair loss in females.CTRI/2018/05/014122Emami Ltd50
撤回
2 期
Ease of Use, Tolerability, Efficacy and Safety of the Vibrant Capsule Administered in the Home EnvironmentConstipationNCT02895516Vibrant Ltd.
已完成
4 期
Observational study to evaluate safety and efficacy of HSTF 02206 in reduction of dark spotsCTRI/2023/03/050307Himalaya Wellness Company100