CTRI/2025/08/093286尚未招募Unknown
A Clinical Study to Evaluate the Anti-Dandruff activity of a regime of Honasa Anti-dandruff Shampoo
Honasa Consumer Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Change in Scalp Dryness/ Hydration
研究概览
简要总结
A single blind one arm study.
Each participant entering the trial will be assigned to a regimen of investigational product with expected wash on Day 0 and 14 with below assessments:
- Scalp Dryness/hydration (corneometery) [Day0(0min, 60min) and Day 14]
- Scalp Sebum [Day0(0min, 60min) and Day 14]
- Dandruff assessment. [Day0(0min, 60min) and Day 14]
-
Questionnaire at Day 14
-
Special Post CT on Day17 (Telephonic)
Volunteers- 32
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
入选标准
- •Gender: Non-pregnant, non-lactating female aged between 18 to
- •Subject with mild to moderate Dandruff
- •Subject willing to give written informed consent
- •Women of child bearing potential must have a negative urine pregnancy test
- •Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
- •Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
- •Have open sore or open lesions in the treatment area
- •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
- •Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
结局指标
主要结局
1. Change in Scalp Dryness/ Hydration
时间窗: Time Points: At T0, T60min, T+14days
2. Scalp Sebum
时间窗: Time Points: At T0, T60min, T+14days
3. Dandruff Assessment
时间窗: Time Points: At T0, T60min, T+14days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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