CTRI/2019/09/021018已完成不适用
An open-label, single-center, safety and efficacy study of a Hair Care Regimen consisting of Hair Oil, Shampoo, Hot Oil Treatment and Oil Replacement used in combination in treatment of hair fall control in healthy adult human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean percentage change in hair fall reduction after 12 weeks of treatment from Baseline on Day 01 before treatment to Day 21, Day 45, Day 63 and Day 90 (±2 Days) after treatment using 60-S Hair count technique.
研究概览
简要总结
Anopen-label, single-center, study to evaluate the safety and efficacy of a HairCare Regimen consisting of Hair Oil, Shampoo, Hot Oil Treatment and OilReplacement used in combination in treatment for hair fall control in healthyadult human subjects.
Total study duration is 90days i.e. 3 Months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age: 18 to 65 years (both inclusive) at the time of consent.
- •Sex: Healthy non-pregnant/non-lactating females.
- •Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit.
- •Subjects generally in good health.
- •Females with 50 count of hair fall from hair combing method (60-sec hair count) at screening visit (if screening and enrollment on same day) or on enrollment day before treatment.
- •Subjects willing to give written informed consent and willing to follow study procedure.
- •Subjects who have used other marketed product for hair fall control in the past.
- •Subjects willing to refrain from any other treatment for the main indications for which the study test products are being given during the course of the study.
- •Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair fall treatment/ hair products other than the test product for the entire duration of the study.
排除标准
- •Subjects with history of severe Hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc.
- •History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •History of prior use of scalp hair growth treatment within 3 months.
- •History of any prior hair growth procedures (e.g., hair transplant or laser).
- •Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
- •History of alcohol or drug addiction.
- •Subjects using other marketed hair fall control products during the study period.
- •Subjects who have plans of shaving of scalp hair during the course of the study.
- •Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Subjects having a history or present condition of an allergic response to any cosmetic products.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
结局指标
主要结局
Mean percentage change in hair fall reduction after 12 weeks of treatment from Baseline on Day 01 before treatment to Day 21, Day 45, Day 63 and Day 90 (±2 Days) after treatment using 60-S Hair count technique.
时间窗: Baseline on Day 01 before treatment, after treatment on Day 21, Day 45, Day 63 and Day 90.
次要结局
- 1. Change in general appearance of hair (Hair Volume, Hair Density, Hair Plasticity, Hair strength, Hair smoothness, Hair Oiliness, Shininess), Change in appearance of scalp skin (itchiness, redness, roughness and scaliness of scalp), Change in hair shine, hair strength & hair frizziness, Measuring overall quality of hair i.e. Hair Thickness, Hair Density and Scalp condition & Product perception.(2. Measuring hair growth phase i.e. % anagen hairs, % telogen hairs and A:T ratio.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
To determine safety and effect of the Ayurvedic Hair Oil in management of Hair Fall Control in healthy adult human subjects with hair fall.CTRI/2022/02/040209Vedistry Private Limited32
已完成
不适用
To Evaluate Efficacy and Safety of KeraScalp Hair Serum in subjects with Mild to Moderate Alopecia of Scalp.CTRI/2022/02/040485A Menarini India Private Limited36
招募中
2 期
Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative ResectionCarcinoma, HepatocellularNCT06454578Qilu Hospital of Shandong University30
尚未招募
不适用
Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic CholangiocarcinomaIntrahepatic CholangiocarcinomaNCT06313554Fudan University63
尚未招募
3 期
Study to Find Out if the New Amrutanjan Headache Roll-On Gives fast Pain Relief in Migraine PatientsCTRI/2025/06/089406Amrutanjan Health Care Limited, Tamil Nadu, India24