An open-label, single-arm, single centre, interventional, prospective clinical safety, efficacy and in-use tolerability study of ThriveCo Dark Patches Corrector Cream and ThriveCo Scalp Clear Serum in healthy adult human subjects having complaint of scalp dandruff and dark patches at different body region (neck, elbows, knees, underarms)
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 Dark Patches Corrector Cream
研究概览
简要总结
This is an 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.
The adult female/male subjects will be instructed to visit the facility as per the below visits
Visit 01 (Day 01): Screening Enrolment, Test Treatment Usage Period (Test Treatment A), Post Usage, Evaluations
Visit 02 (Day 08+2 Days): Scalp Evaluation, End of Study (Test Treatment B)
Visit 03 (Day 21+2 Days): Test Treatment Usage Period, Evaluation Phase
Visit 04 (Day 45+2 Days): Evaluation Phase, End of Study (Test Treatment A)
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •60 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 hyperpigmentation/post inflammatory hyperpigmentation/ melasma/ acanthosis nigricans. 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 dandruff control and/or dark patch removal/corrector product 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 at the reading site that can interfere with the reading.
- •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 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 Dark Patches Corrector Cream
时间窗: 1. ThriveCo Dark Patches Corrector Cream- | From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 (+2 Days) and Day 45 (+2 Days). | 2. ThriveCo Scalp Clear Serum- | From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08 (+2 Days)
1.To evaluate the effectiveness of the test treatment in terms of change in dark spots| patches of the skin.
时间窗: 1. ThriveCo Dark Patches Corrector Cream- | From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 (+2 Days) and Day 45 (+2 Days). | 2. ThriveCo Scalp Clear Serum- | From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08 (+2 Days)
2.To evaluate the effectiveness of the test treatment in terms of change in hyperpigmentation score.
时间窗: 1. ThriveCo Dark Patches Corrector Cream- | From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 (+2 Days) and Day 45 (+2 Days). | 2. ThriveCo Scalp Clear Serum- | From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08 (+2 Days)
2. ThriveCo Scalp Clear Serum
时间窗: 1. ThriveCo Dark Patches Corrector Cream- | From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 (+2 Days) and Day 45 (+2 Days). | 2. ThriveCo Scalp Clear Serum- | From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08 (+2 Days)
1.To evaluate the effectiveness of the test treatment in terms of change in Adherent Scalp Flaking Score.
时间窗: 1. ThriveCo Dark Patches Corrector Cream- | From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 (+2 Days) and Day 45 (+2 Days). | 2. ThriveCo Scalp Clear Serum- | From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08 (+2 Days)
次要结局
- To assess the effectiveness of the test treatment(ThriveCo Dark Patches Corrector Cream) in terms of change in digital photographs(From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 and Day 45)
- To assess the effectiveness of the test treatment (ThriveCo Dark Patches Corrector Cream) in terms of consumer perception(From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 and Day 45)
- To evaluate the effectiveness of the test treatment (ThriveCo Scalp Clear Serum) in terms of change in scalp appearance(From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08.)
- To assess the effectiveness of the test treatment (ThriveCo Scalp Clear Serum) in terms of changes in scalp phototrichogram(From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08.)
- To assess the effectiveness of the test treatment (ThriveCo Scalp Clear Serum) in terms of consumer perception(From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited