CTRI/2022/04/041710已完成未知
A Proof-Of-Concept, Safety and Efficacy study of Hair Fall Control Oil Shots to Evaluate Reduction in Hair Fall in Healthy Adult Human Subjects with Hair Fall
Brillare Science Private Limited0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Age: 18 to 65 years (both inclusive) at the time of consent.
- •2)Sex:Ã? Healthy males and non-pregnant/non-lactating females.
- •3)Females of childbearing potential must have a self-reported negative pregnancy test.
- •4)Subjects are generally in good health.
- •5)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 product application.
- •6) Subjects have unwashed and untreated scalp for 5 days.
- •7)Ã? All hair colours except grey hair.
- •8)Ã? The subject who does head massage.
- •9)Subjects with self-proclaimed nonpathological thinning of hair. Ã?Â
- •10)Subjects willing to give written informed consent and willing to follow study procedure.
- •11)Subjects who have used other marketed products for hair fall control in past.
- •12)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.
- •13)Willing to use test product throughout the study period.
排除标准
- •1)Subjects with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.
- •2)Ã? History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3)Ã? History of prior use of scalp hair growth treatment within 3 months.
- •4)Ã? History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5)Ã? 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.
- •6) History of alcohol or drug addiction.
- •7)Ã? Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •8)Ã? Subjects who have plans of shaving of scalp hair during the study.
- •9)Ã? Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10)Ã? History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •11)Ã? Subjects having a history or present condition of an allergic response to any cosmetic products.
- •12)Ã? Any other condition which could warrant exclusion from the study, as per the dermatologistââ?¬•s/investigatorââ?¬•s discretion.
- •13)Ã? Pregnant or breastfeeding or planning to become pregnant during the study period.
- •14)Ã? History of chronic illness which may influence the cutaneous state.
- •15)Ã? Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks.
研究者
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