A Randomized, Single blinded, Placebo controlled Clinical Study to Assess the Efficacy and Safety of MEERA Anti Dandruff powder in patients suffering from dandruff disorders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1. Total Dandruff Severity Score (TDSS)
研究概览
简要总结
Thesubjects who fulfilled the inclusion and exclusion criteria will be enrolled inthe study. The selected subjects will be asked to self-administer the MEERA anti dandruff hair washpowder as per the dosing instructions. The evaluation visits are as follows,
Visit 1 (Day 1)- Screening and Baseline evaluationday before wash in period, and starting of Placebo), screening, obtaining ICFand questionnaire.
Visit 2- (Day 8)-1st week-(After 1 weekof Placebo usage)- End of Placebo Study & Active samples Placement. Dermatologistassessment and sensory feedback will be collected from each volunteer
Visit 3-(Day 22)- 3rd week -(End of Active sample**)**- (After 2weeks of Active sample usage)- Placement of Placebo- Recurrence phase. Dermatologist assessment andsensory feedback will be collected from each volunteer
Visit 4-(Day 30) 4th week- (After 1 weekof placebo). End of Recurrence phase -Study closure- Dermatologist assessmentand sensory feedback will be collected from each volunteer
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant 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
- •1.Male and female subjects who are 18 to 45 years of age.
- •Subjectssuffering from Dandruff of scalp
- •Subjects who are committed not to use medicated/non medicated shampoos/soaps (including soaps containing antibacterial/antifungal agents) or any other antidandruff treatment/hair products (including prescription and non-prescription medications such as hair oil, conditioners) for the entire duration of the study.
- •Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
- •Subjects not have participated in any other clinical trial during the past 3 months.
排除标准
- •Scalp Psoriasis.
- •Subjects who underwent any type of hair procedures within the past 2 weeks or during the study.
- •Subjects with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.
- •Subjects undergoing treatment for immune-compromised conditions/psychiatric illness.
- •Subjects with any other co- morbid conditions like Diabetes that can affect the study outcome.
- •Pregnant or lactating women.
- •Hypersensitivity to any of the components of the test formulation.
- •The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
结局指标
主要结局
1. Total Dandruff Severity Score (TDSS)
时间窗: Week 1, 2, 3 and 4
2. Changes in the intensity of hair fall over 4 weeks from baseline to final treatment visit using Visual Analogue Scale (VAS)
时间窗: Week 1, 2, 3 and 4
3. Global improvement (self-assessment scoring& Photographs) by the subject.
时间窗: Week 1, 2, 3 and 4
4. Pull test – to evaluate the severity of hair shedding.
时间窗: Week 1, 2, 3 and 4
次要结局
- To monitor for any adverse events during the study period and assess quality of life(Week 1, 2, 3 and 4)