An open-label, single-arm, single centre, interventional, prospective, clinical safety, efficacy and in-use tolerability study of ThriveCo Scalp Kit (ThriveCo Exfoliating Scalp Scrub and ThriveCo Scalp Vitalizing Serum) and ThriveCo Acne Kit (ThriveCo Acne Cleanser and ThriveCo Acne Serum) in healthy adult human subjects having complaint of scalp dandruff and facial acne.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. ThriveCo Scalp Kit
研究概览
简要总结
This is open-label, single-arm, single centre, interventional, prospective clinical study to evaluate the safety, efficacy and in-use tolerability of the test treatments in healthy adult human subject.
a maximum of 32 subjects will enrolled to 30 subject complete the study.
subjects will be instructed to visit the facility as per the below visits.
Visit 01 (Day 01): screening, Enrolment, Test Treatment Usage Period, Post Usage 1st Wash, Evaluation
Visit 02 (Day 08): Evaluation Phase, Test Treatment Usage Period
Visit 03 (Day 15): Test Treatment Usage Period, End of the Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •50 above (both inclusive) old at the time of consent. 2)Sex: Healthy males and non-pregnant/non-lactating females. 3)Females of childbearing potential must have a self-reported negative urine pregnancy test. 4)Subjects are generally in good general health as determined from recent medical history. 5)Subjects with mild to moderate dandruff status as per ASFS at screening. 6)Subject have unwashed and untreated scalp for 5 days. 7)Subject must have mild to moderate acne on their skin (IGA score 2 to 3). 8)The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits. 9)The subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Subject with known allergy or sensitization to test treatment ingredients.
- •History of dermatological condition of scalp other than dandruff.
- •History of alcohol or drug addiction.
- •Subject using other marketed products for acne and dandruff control and/or hair growth products during the study period.
- •Subject who have plans of shaving scalp hair during the study.
- •The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
- •Be wearing any facial makeup on the day of the study visit.
- •Medication which may affect skin and scalp response and/or past medical history.
- •Subject has any concurrent skin disease.
- •Subject has taken any systemic corticosteroids, anti-bacterial, immunosuppressant drugs or abradant facial procedures in the past 30 days.
- •Subjects who are likely to engage in activities that involve excessive exposure to sunlight.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
- •Subjects who have been treated with topical steroids, retinoids or other topical drugs within 2 weeks prior to entry to the study.
- •Participation in other clinical studies simultaneously.
结局指标
主要结局
1. ThriveCo Scalp Kit
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
1) To assess the effectiveness of the test treatment in terms of change in Adherent Scalp Flaking Score.
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
2) To assess the effectiveness of the test treatment in terms change in hair thickness, hair density and scalp condition.
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
3) To assess the effectiveness of the test treatment in terms of change in scalp skin hydration
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
2. ThriveCo Acne Kit
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
1) To assess the effectiveness of the test treatment in terms of change in inflammatory and non-inflammatory lesion.
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
2) To assess the effectiveness of the test treatment in terms of change in skin hydration.
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
3) To assess the effectiveness of the test treatment in terms of change in skin sebum level.
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
4) To assess the effectiveness of the test treatment in terms of change in facial dark spot i.e. blemishes
时间窗: 1. ThriveCo Scalp Kit | From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days) | 2. ThriveCo Acne Kit | from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days)
次要结局
- 1.To assess the effect of the test treatment(Scalp Kit) in terms of change in scalp appearance i.e. dryness, itchiness, redness, and scaliness(From Baseline before usage of the test treatment on Day 01 and after usage of the test treatment on Day 01, Day day 08 and Day 15)
- 2.To assess the effect of the test treatment(Scalp Kit) in terms of change in scalp photographs using CASLite Nova(From Baseline before usage of the test treatment on Day 01 and after usage of the test treatment on Day 01, Day day 08 and Day 15)
- 3.To assess the effect of the test treatment (Scalp Kit) in terms of treatment perception questionnaire using 9-point hedonic scale(After usage of the test treatment on Day 01, Day day 08 and Day 15)
- 4. To assess the effectiveness of the test treatment (Acne kit) in terms of change in acne severity using IGA scale(From baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08, and Day 15.)
- 5.To assess the effectiveness of the test treatment (Acne Kit) in terms of change in facial photographs (left/right/center)(From baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08, and Day 15)
- 6. To assess the effectiveness of the test treatments (Acne Kit) in terms of treatment perception questionnaire using 9-point hedonic scale(After usage of the test treatment on Day 01, Day day 08 and Day 15)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited