CTRI/2022/04/041701已完成未知
A Proof-Of-Concept, Safety and Efficacy Study of DandruffControl Oil Shots to Evaluate Reduction in Scalp Dandruff inHealthy Adult Human Subjects with Dandruff on Scalp
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: 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) Subject has mild to moderate dandruff on scalp determined by ASFS score 24 to 48 with
- •itching and flaking at the screening visit.
- •6) Subjects have unwashed and untreated scalp for 3-5 days.
- •7) All hair colors except grey hair.
- •8) The subject who does head massage.
- •9) Subjects with self-proclaimed nonpathological thinning of hair.
- •10) Subjects willing to give written informed consent and willing to follow the study procedure.
- •11) Subjects who have used other marketed products for Dandruff control in past.
- •12) Subjects who commit not to use medicated/ prescription shampoos/hair care products
- •(containing Minoxidil / Anti-hair fall agents / Anti-Dandruff) or any other hair growth, hair
- •fall treatment, dandruff control, 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
- •anemia, 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 scalp 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 scalp dandruff control products during the study period.
- •8) Subjects who have plans of shaving of 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
- •12) Any other condition which could warrant exclusion from the study, as per the
- •dermatologistââ?¬•s/investigatorââ?¬•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, dandruff control, device or therapeutic
- •trials or hair/scalp care products within the last four weeks.
研究者
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