A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a Unani Formulation in Kalaf (Melasma).
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 25% reduction in MASI score from the baseline after 8 weeks of treatment.
研究概览
简要总结
Kalaf (Melasma) is a common acquired disorder of hyperpigmentation characterized by irregular light to dark brown macules on the sun exposed area of the face. The prevalence of melasma ranges from 8.8% to 40%.It affects all age population but mostly common in 21-44 years age group.Melasma affects all races especially Hispanics, Asians, Africans, Arab and mostly affects person with darker skin type. Exact cause of melasma is unknown, but various risk factors that play an important role to aggravate melasma i.e. uncontrolled sun exposure, pregnancy, hormonal influences, darker phenotype, genetic factors. It produces considerable impact on the patient’s quality of life. It further produces psychological upset in the form of low self-esteem, nervousness, irritation, depression and anxiety. Melasma is a curable disease but it requires long term treatment. It has been observed that recurrence after cessation of treatment is a most common problem. Conventional therapy such as application of hydroquinone produces various side effects like dermatitis, post inflammatory pigmentation. Nowadays cosmetics having metal which are very dangerous to the health are being used. Hence it is felt that there is a need to search for safe and effective treatment for melasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Participant having single or multiple, symmetrical or asymmetrical brown macules on face, cheeks, nose, forehead, upper lip and chin.
排除标准
- •a) Women who are pregnant, and lactating.
- •b) Participant aged <18 years or >55 years.
- •c) Significant cardiovascular/ pulmonary/ hepatorenal dysfunction.
- •d) Known case of diabetes mellitus, HIV/ AIDS and malignancy.
- •e) Those unwilling to come for regular follow-up for the entire duration of the study and any patients considered not eligible according to the investigator’s discretion during the study.
结局指标
主要结局
25% reduction in MASI score from the baseline after 8 weeks of treatment.
时间窗: 8 Weeks
次要结局
- improvement in quality of life.(8 weeks)
