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临床试验/CTRI/2025/02/080241
CTRI/2025/02/080241已完成Unknown

A Clinical Study to Evaluate the Efficacy of 3% Niacinamide & Rice Water Toner for skin Brightening

Pureplay Skin Sciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年2月17日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
4. Change in Temperature

研究概览

简要总结

A single Blind One Arm Study

Test Product: 3% Niacinamide & Rice Water Toner

Dose: How to use- Keep eyes closed and spritz toner on cleansed face and neck. Let it air dry. Use twice a day.

Route of Administration: Topical

**Follow ups:**Day 0, Day 3, and Day 7

Assessment Time:

  1. Change in Skin smoothness

  2. Change in skin Gloss

  3. Change in skin pH

4. Change in Temperature

5. Change in the Moisture content

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 (Female:Male ratio to be 80:20) 2) Subjects willing to give written informed consent 3) 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

  • 1.Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
  • 2.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
  • 3.Have open sores or open lesions in the treatment area(s).
  • 4.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
  • 5.Have participated in any interventional clinical trial in the previous 30 days.
  • 6.Have a known sensitivity to any of the constituents of the test product including sensitivities to (mention some of active ingredient’s name) 7.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
  • 8.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

4. Change in Temperature

时间窗: T0min, T30Min, T3Days, T7Days

5. Change in the Moisture content

时间窗: T0min, T30Min, T3Days, T7Days

1. Change in Skin smoothness

时间窗: T0min, T30Min, T3Days, T7Days

2. Change in skin Gloss

时间窗: T0min, T30Min, T3Days, T7Days

3. Change in skin pH

时间窗: T0min, T30Min, T3Days, T7Days

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Pureplay Skin Sciences 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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