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临床试验/CTRI/2025/02/080649
CTRI/2025/02/080649已完成Unknown

A Clinical Study to Evaluate the Anti-pigmentation and brightening activity of Plum Vitamin C Serum

Pureplay Skin Science 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2月25日

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
1. Change in Skin Pigmentation

研究概览

简要总结

An open label one arm study to check Saftey and tolerability for anti-pigmentation and brightness

Assessment Points:

Skin Gloss by Glossymeter (T0, T1 hour, Day 5, and 14)

Skin Pigmentation by Mexameter Face(Melanin Index) (Day 0, 5, 14)

Skin Hydration by Corneometer (T0, T1hour)

Dark Spots by Visioface (Day 0, 5, 14)

Skin discoloration by Chromameter as L value in L*a*b space (Day 0, 5, 14)

Skin Barrier by TEWAMETER (Day 0, 5, 14)

Test Duration-14 volunteers, 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: Male or Female with age 18-45 2) Subjects with pigmented skin, with a self-declared pigmented due to UV exposure.
  • 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

  • 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

1. Change in Skin Pigmentation

时间窗: T0min, T1hrs, T7Days, T14Days

2. Change in skin Gloss

时间窗: T0min, T1hrs, T7Days, T14Days

3. Change in skin hydration

时间窗: T0min, T1hrs, T7Days, T14Days

4. Change in Tewameter

时间窗: T0min, T1hrs, T7Days, T14Days

5. Change in Skin discoloration

时间窗: T0min, T1hrs, T7Days, T14Days

6. Dermat Evaluation on a 5 point ordinal scale

时间窗: T0min, T1hrs, T7Days, T14Days

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Pureplay Skin Science 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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