An Open Label, Single-Arm, Multicentre, Clinical Study to Evaluate Efficacy and Safety of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The objective of this study is to evaluate the safety and efficacy of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff
研究概览
简要总结
Dandruffis a common condition encountered in general population and it is also known asPityriasis capitis. It is said that dandruff affects at least 50% of the world’sadult population and about 15-20% of the world’s total population. The peakincidence and severity of dandruff occurs at approximately 20 years of age.
Dandruff is a common scalp condition,characterized by presence of corneocytes that form clusters due to their highcohesive power, in the form of flaky white to yellowish scales, accompanied byitching. It has been observed that dandruff occurs mainly between puberty tomiddle- age, the phase when sebaceous glands are most active.
This is an open label, single-arm, multicenter, clinical study toevaluate efficacy and safety of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff. The potential subjects will be screenedas per the inclusion and exclusion criteria only after obtaining writteninformed consent from the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 to 60 years (both inclusive) at the time of consent.
- •2.Sex: Healthy male or non-pregnant/non-lactating female.
- •3.Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening visit and Enrolment.
- •4.Subjects generally in good health and willing to give written informed consent and willing to follow study procedure.
- •5.Subjects with dandruff determined by ASFS score 24 to 48 with itching and flaking.
- •6.Subjects with visible flakes.
- •7.Subjects willing to refrain from using other products on the scalp other than those provided, including other shampoos/conditioners, scalp and hair treatment and oils/ products that has anti-dandruff action during the study period.
- •8.Subjects completing the conditioning phase.
- •9.Subjects willing to use test product throughout the study period.
- •10.Subjects must be able to understand and provide written informed consent to participate in the study.
- •11.Subjects should be willing and able to follow the study protocol to participate in the study.
排除标准
- •History of any dermatological conditions of the scalp (other than dandruff or seborrheic dermatitis) that would interfere with the diagnosis or assessment (e.g. psoriasis, eczema, atopic dermatitis, or other skin/scalp infections).
- •Subjects with excessive erythema, crusting or a significant number of pustules/papules on the scalp.
- •History of skin cancer or treatment for any type of cancer within the last 2 years.
- •History of prior use of antidandruff treatment on scalp within past 1 month.
- •Participation in a similar clinical study within the previous 90 Days.
- •Subjects with a history or present condition of an allergic response to dandruff shampoos or any cosmetic products or component present in the test product.
- •Any other condition which could warrant exclusion from the study, as per the Dermatologist’s/investigator’s discretion.
结局指标
主要结局
The objective of this study is to evaluate the safety and efficacy of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff
时间窗: Day 01, Day 07, Day 15, Day 28, Day 30, Day 31 and Day 32
次要结局
- Not Applicable(Not Applicable)