Evaluating Anti dandruff Efficacy of Hair Leave on Products on Healthy Human Subjects Based on Half Head Application Design.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- -Significant difference between the test products in conferring a reduction in dandruff symptoms.
研究概览
简要总结
primary Objective - To study the efficacy of test product in conferring superior reduction in dandruff symptoms and related discomfort compared to the reference product , to study the efficacy of test product in retarding / delaying dandruff recurrence compared to the reference product , to study the efficacy of the test product in conferring superior hair quality and scalp health compared to the reference product .
secondary objective - To study the tolerability and efficacy of the test products in conferring improved scalp health and hair attribute benefits.
sample size - Total of 50 healthy human adult subjects : male and female with moderate to severe dandruff.
study duration : Approximately 10 weeks for each subject.
study visits : Total 19 visits
study design : A controlled , parallel , comparative , randomized double blind study half head application design .
Main assessment parameters : dermatological visual assessment , black card assessment of falling flakes , hair fall count , and subject self assessment .
Results:The superior reduction in dandruff symptoms and related discomfort compared to the reference product wa observed. The retarding / delaying dandruff recurrence compared to the reference product was observed in some subjects. The iprovement in hair quality and scalp was observed in female subjects.The test product was well accepted by subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who are willing to give signed informed consent and who consent to abide by the study protocol and restrictions for the entire study duration.
- •2.A mixed population of healthy male and female subjects in the age group of 20-45 yrs.
- •3.Subjects with preferably lengthy hair (for female subjects) but not mandatory.
- •4.Subjects with moderate to severe scalp dandruff score (with dandruff on both sides of the scalp).
- •5.Subjects with moderate to severe scalp itch score (Scoring based on subject’s feedback) 6.Subjects who have not participated in a similar investigation in the past four weeks.
- •7.Subjects who are not sensitive to the ingredients of the test product (As disclosed by the subjects or as observed during the Skin sensitivity test).
排除标准
- •1.Subjects with a known history or present condition of allergic response to any shampoo or conditioner.
- •2.Subjects having communicable skin/scalp infections or other skin disease (e.g. psoriasis, atomic dermatitis or other cutaneous manifestations), which could interfere with the test results as diagnosed by Dermatologist.
- •3.Subjects with severe hair fall due to endocrine disorders as diagnosed by dermatologist or revealed through oral interview.
- •4.Subjects on medications (steroids, antihistamines, antimicrobials), which would compromise the study results (Subjects inputs).
- •5.Female subjects who are pregnant (determined by Urine pregnancy test), lactating, or planning pregnancy during the course of the study (Subjects inputs).
- •6.Subjects with signs and symptoms of systemic and / or chronic illness (As diagnosed by Dermatologist) 7.Subjects who are regular users of anti- dandruff shampoo/ undergoing therapy for dandruff (Subjects inputs).
结局指标
主要结局
-Significant difference between the test products in conferring a reduction in dandruff symptoms.
时间窗: Approximately 10 Weeks for each subjects
-Significant difference between the test products in delaying the recurrence of dandruff symptoms.
时间窗: Approximately 10 Weeks for each subjects
-Significant difference between the test products in conferring improvement in hair quality and scalp health.
时间窗: Approximately 10 Weeks for each subjects
次要结局
- -No significant difference between the test products in tolerability and efficacy in conferring scalp and hair attribute benefits.(Approximately 10 Weeks for each subjct.)