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临床试验/CTRI/2025/10/096426
CTRI/2025/10/096426尚未招募Unknown

A Single-Arm, Open-Label Clinical Study to Assess the Efficacy and Safety of Baypure Vitamin C & Ferulic Acid Serum in Enhancing Skin Brightness and Improving Overall Skin Health Parameters

Baypure Lifestyle Pvt Ltd1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年11月5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
35
试验地点
1
主要终点
1. change in Skin Gloss or brightness

研究概览

简要总结

To evaluate the efficacy of Vitamin C & Ferulic Acid Serum in improving skin brightness and radiance

after 28 days of application.

Males and females aged 18–45 years.

Type: Prospective, single-arm, open-label study.

Duration: 28 days.

Visits: Baseline (Day 0), Interim (Day 14), End of Treatment (Day 28).

Application: 5–6 drops applied topically on face and neck, twice daily, for 4 weeks.

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)(—)
性别
All

入选标准

  • Males and females aged 18–45 years.
  • Subjects with dull and mildly pigmented skin.
  • Willingness to provide written informed consent.
  • Female participants of childbearing potential: negative urine pregnancy test at screening.
  • Willing to avoid excessive sun exposure during study duration.
  • Free from systemic or dermatological disorders that may interfere with results.

排除标准

  • Pregnant or lactating women or those planning pregnancy during the study.
  • History of skin cancers within the past 5 years.
  • Presence of active skin disease or open lesions or infections in the treatment area.
  • Known allergy to Vitamin C, Ferulic Acid, or excipients in the test product.
  • Use of systemic corticosteroids or immunosuppressive or biologic therapies within 90 days.
  • Participation in another interventional study within the past 90 days.

结局指标

主要结局

1. change in Skin Gloss or brightness

时间窗: At t0, t30min, t14days, t28days

2. change in Skin Lightness

时间窗: At t0, t30min, t14days, t28days

3. change in Pigmentation

时间窗: At t0, t30min, t14days, t28days

4. change in Hydration

时间窗: At t0, t30min, t14days, t28days

5. change in TEWL

时间窗: At t0, t30min, t14days, t28days

6. Dark Spots by visioscan

时间窗: At t0, t30min, t14days, t28days

7. Texture & Smoothness

时间窗: At t0, t30min, t14days, t28days

8. DSLR Imaging

时间窗: At t0, t30min, t14days, t28days

次要结局

  • SGA(At t28 days)

研究者

发起方
Baypure Lifestyle 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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