CTRI/2022/11/047330已完成未知
A Proof-Of-Concept, Safety and Efficacy Study of Hair Growth Promoting Product in Healthy Adult Human Subjects with Hair Fall Complaints
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 29
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 45 years (both inclusive) 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 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 test product usage.
- •6)Subject has hair length long enough to pluck the hairs.
- •7)Subjects have unwashed and untreated scalp for 5 days.
- •8)All hair colours except grey hair.
- •9)Subjects with self-proclaimed nonpathological thinning of hair.
- •10)Subjects are willing to give written informed consent and are willing to follow the 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, or 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)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3)History of prior use of hair fall control | hair growth treatment within 3 months.
- •4)History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5)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)Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •8)Subjects who have plans of shaving scalp hair during the study.
- •9)Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •11)Subjects having a history or present condition of an allergic response to any cosmetic products.
- •12)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •13)Pregnant or breastfeeding or planning to become pregnant during the study period.
- •14)History of chronic illness which may influence the cutaneous state.
- •15)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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