跳至主要内容
临床试验/CTRI/2025/06/089160
CTRI/2025/06/089160尚未招募Unknown

A Clinical Study to Evaluate Anti-sebum activity of Nia-Zelaic Oil Control Face Serum

Honasa Consumer Limited1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年6月30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
10
试验地点
1
主要终点
1. Change in Sebum

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 the below assessments.

Product is applied on half of the face, and no product is applied on the other half, with sebum assessment at different timepoints to study the comparative reduction in sebum production.

  • Sebum by Sebumeter

Assessment Time: T0min, T+3 hr, T+6 hr

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: Male or Female with age 18-45 2) Subjects with oily skin.
  • Subjects willing to give written informed consent 4) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
  • Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
  • 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 systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
  • Have open sores or open lesions in the treatment area(s).
  • Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
  • Have participated in any interventional clinical trial in the previous 90 days.
  • Have a known sensitivity to any of the constituents of the test product including sensitivities to product ingredients
  • Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
  • Have not skin related issues.

结局指标

主要结局

1. Change in Sebum

时间窗: At Day1 T0, T3hrs, T6hrs

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Honasa Consumer Limited
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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