A Safety and Efficacy study of an Ayurvedic Hair Oil in Management of Hair Fall (Khalitya) Control in Healthy Adult Human Subjects with Hair Fall (Khalitya).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1) Mean Percentage change in hair fall (Khalitya) reduction after 4 and 8 weeks of the application using 60 seconds hair count technique
研究概览
简要总结
This is an open-label, single-arm, single-centre, safety and efficacy, a clinical study of ayurvedic hair oil in the management of hair fall (Khalitya) control in Healthy Adult Human Subjects with Hair Fall (Khalitya) after usage of consecutive 8-weeks.
In this study, a detailed sample size calculation has not been performed. Considering proof of concept study and based on the sponsor’s recommendations 30 completed subjects (32 enrolled) are kept.
A total of up to 32 subjects will be enrolled to get 30 evaluable subjects [preferably equal number of males and females] in the study.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
There will be 06 visits during the conduct of the study. The duration of the study will be 60 Days (+2 days) from enrolment.
Visit 01 (Day -04): Screening Visit (Within 4 days before enrolment on Day 01), Enrollment, & Tattoo on Scalp, Hair Growth Measurement, 60s Combing test
Visit 02 (Day 01): Hair Growth Measurement, Evaluation Visit, Treatment Phase start
Visit 03 (Day 27): Treatment Phase, Evaluation Visit (Day 27 i.e., 03 days before visit 04), Hair Growth Measurement
Visit 04 (Day 30): Treatment Phase, Evaluation Visit, Hair Growth Measurement [Week 4]
Visit 05 (Day 57): Treatment Phase, Evaluation Visit (Day 57 i.e., 03 days before visit 04), Hair Growth Measurement
Visit 06 (Day 60): Evaluation Visit, Hair Growth Measurement, End of Study [Week 8]
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Â Age: 18 to 45 years (both inclusive) at the time of consent.
- •Â Sex:Â Healthy males and non-pregnant/non-lactating females.
- •Â Females of childbearing potential must have a self-reported negative pregnancy test.
- •Â Subjects are generally in good health.
- •Â Females with 40-50 counts and males with 25-30 counts of hair fall from the hair combing method (60-sec hair count) at the screening visit 1 before treatment.
- •Â Subject has mild to moderate dandruff on scalp determined by ASFS score 24 to 48 with itching and flaking at the screening visit.
- •Subjects have unwashed and untreated scalp for 5 days.
- •Â All hair colors except grey hair.
- •Â The subject who does head massage.
- •Â Subjects with self-proclaimed nonpathological thinning of hair.
- •Â 12)Â Subjects willing to give written informed consent and willing to follow study procedure.
- •Â Subjects who have used other marketed products for hair fall control in past.
- •Â Willing to refrain from any other treatment for the main indications for which the study test product is being given during the study.
- •Â Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair growth, hair fall treatment, hair products other than the test product for the entire duration of the study.
- •Â Willing to use test products throughout the study period.
排除标准
- •Â Subjects with a history of severe hair fall due to any clinically significant problems/s like anemia, thyroid problems, etc.
- •Â History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •Â History of prior use of scalp hair growth treatment within 3 months.
- •Â History of any prior hair growth procedures (e.g., hair transplant or laser).
- •Â Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •Â History of alcohol or drug addiction.
- •Â Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •Â Subjects who have plans of shaving of scalp hair during the study.
- •Â Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •Â History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Â Subjects having a history or present condition of an allergic response to any cosmetic products.
- •Â Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Â Pregnant or breastfeeding or planning to become pregnant during the study period.
- •Subjects participating in other similar cosmetics, device or therapeutic trials or hair / scalp care products within the last four weeks.
结局指标
主要结局
1) Mean Percentage change in hair fall (Khalitya) reduction after 4 and 8 weeks of the application using 60 seconds hair count technique
时间窗: 1) Baseline on Day 1 before application to Day 30 and Day 60 after applications | 2) Baseline visit (04 days before Day 01) and Visit 2 (Day 01) before application to Visit 03 (Day 27) - Visit 04 (Day 30) and Visit 05 (Day 57) - Visit 06 (Day 60) after application | 3) Baseline on Day 01 before application to Day 30 and Day 60 after application
2) To assess the effect of test treatment in terms of change in hair growth on the scalp using CASlite nova
时间窗: 1) Baseline on Day 1 before application to Day 30 and Day 60 after applications | 2) Baseline visit (04 days before Day 01) and Visit 2 (Day 01) before application to Visit 03 (Day 27) - Visit 04 (Day 30) and Visit 05 (Day 57) - Visit 06 (Day 60) after application | 3) Baseline on Day 01 before application to Day 30 and Day 60 after application
3) To evaluate the effectiveness of test product on reduction in Adherent scalp flaking score
时间窗: 1) Baseline on Day 1 before application to Day 30 and Day 60 after applications | 2) Baseline visit (04 days before Day 01) and Visit 2 (Day 01) before application to Visit 03 (Day 27) - Visit 04 (Day 30) and Visit 05 (Day 57) - Visit 06 (Day 60) after application | 3) Baseline on Day 01 before application to Day 30 and Day 60 after application
次要结局
- To assess the effect of test treatment in terms of change in the general appearance of hair (Hair volume, hair density, hair plasticity, hair smoothness, hair oiliness, shininess)(Hair Volume: Full - Medium - Small)
- To assess the effect of the test treatment in terms of hair Strength (poor, average, good)(Baseline on Day 1 before application to Day 30 and Day 60 after applications)
- To assess the effect of test treatment in terms of product perception(Baseline on Day 1 before application to Day 30 and Day 60 after applications)