CTRI/2022/03/040886已完成不适用
An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of Vatika Dandruff Guard Shampoo in subjects with moderate to severe scalp dandruff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.Effect of test product in Dandruff Reduction by using visual dandruff scoring scale at Day 01 (before application & after application)
研究概览
简要总结
This is an open label, single-arm, clinical study toevaluate efficacy and safety of Vatika Dandruff Guard Shampoo in subjects withmoderate to severe scalp dandruff.
The potential subjects will be screened as per theinclusion and exclusion criteria only after obtaining written informed consentfrom the subjects.
There are total 4 visits in the study i.e.
Visit01: Screening and conditioning period (Within30 days prior to Day 01 including at least 07 days of conditioning period)
Visit02: Enrolment (Day 1) – Pre and Post wash assessment
Visit03: Evaluation Phase [Day 15 (± 2 Days)]
Visit04: Evaluation Phase and End of Study (EOS) [Day 30 (± 2 Days)]
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.Subject generally in good health and willing to give written informed consent and willing to follow study procedure.
- •5.Subject has moderate to severe scalp dandruff based on the visual evaluations by dermatologist with visual scoring in between 5 to 10 at screening.
- •6.Subject with visible flakes.
- •7.Subject’s scalp is free from cuts and abrasions.
- •8.Subject 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.
- •9.Subject has hair that can be parted and held with hair clips to allow instrumental readings to be taken as 2 sites.
- •10.Subject willing to complete the condition phase.
- •11.Subject willing to use test product throughout the study period as instructed.
- •12.Subject must be able to understand and provide written informed consent to participate in the study.
- •13.Subject should be willing and able to follow the study protocol to participate in the study.
排除标准
- •1.Pregnant or breastfeeding or planning to become pregnant during the study period.
- •2.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).
- •3.Subject with excessive erythema, crusting or a significant number of pustules/papules on the scalp.
- •4.Subject having any type of diabetes.
- •5.History of skin cancer or treatment for any type of cancer within the last 2 years.
- •6.History of prior use of antidandruff treatment on scalp within past 1 month.
- •8.History of alcohol or drug addiction.
- •9.Use of anti-histamines, anti-fungal medications or anti-inflammatories.
- •10.Subject who have plans of shaving of scalp hair during the course of the study.
- •11.Subject with a history or present condition of an allergic response to dandruff shampoos or any cosmetic products or component present in the test product.
- •12.Participation in a similar clinical study within the previous 90 Days.
- •13.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
1.Effect of test product in Dandruff Reduction by using visual dandruff scoring scale at Day 01 (before application & after application)
时间窗: Day 15 and Day 30
次要结局
- 1.To evaluate the effect of test product in reduction/prevention in visible dandruff flakes using Dandruff Meter DA 20 at Day 01 (before application & after application)(Day 15 and Day 30)
- 2.Effect of test product on improvement in the clinical condition of scalp on the basis i.e. Global improvement rating performed by the Dermatologist(Day 15 and Day 30)
- 3.Effect of test product on reduction in itching evaluated through VAS (0-10) score(change from baseline i.e. Day 01 before application to Day 15 and Day 30)
- 4.Evaluation for healthy scalp and hair through subjective questionnaire(Day 1 (before application & after application), Day 15 and Day 30)
- 5.To assess the suitability of test product / subject response index [consumer perception about product] for all hair types (normal, oily, dry, colored (synthetic and henna colored) and permed hair)(Day 15 and Day 30)
研究者
研究点 (1)
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