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临床试验/CTRI/2025/08/092970
CTRI/2025/08/092970尚未招募Unknown

A Clinical Study to Evaluate the Anti-Dandruff activity of a regime of Man Matters Advance Daily Use Anti-Dandruff Shampoo

Mosaic Wellness Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月23日

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, 3 and 7 with below assessments:

-  Scalp Dryness/hydration (corneometery) [Day0(0min, 60min) and Day 7]

-  Scalp Sebum [Day0(0min, 60min) and Day 7]

-  Dandruff assessment. [Day0(0min, 60min) and Day 7]

  • Dinolite Imaging [Day0(0min, 60min) and Day 7]

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 45, with female:male ratio as 80:20
  • 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+7days

2. Scalp Sebum

时间窗: Time Points: At T0, T60min, T+7days

3. Dandruff Assessment

时间窗: Time Points: At T0, T60min, T+7days

4. Dinolite Imaging

时间窗: Time Points: At T0, T60min, T+7days

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Mosaic Wellness Pvt. Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Robin Chugh

CCFT Laboratories

研究点 (1)

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