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临床试验/CTRI/2025/09/095336
CTRI/2025/09/095336尚未招募Unknown

A single arm clinical study to evaluate the efficacy of the Vitamin C in improving skin brightness and enhancing overall skin parameters

UAS Pharmaceuticals Pty Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
32
试验地点
1
主要终点
1. change in Skin Gloss

研究概览

简要总结

An open label one arm study.

Each participant entering the trial will be assigned to a regimen of investigational product with the below assessments.

Product to be applied at face and neck both.

  • Skin Gloss by Glossymeter (T0, day 14 and day 28 )

  • Skin Pigmentation by Mexameter Face (Melanin Index) (Day 0, 14, 28)

  • Skin Hydration by Corneometer (T0, day14 and day 28)

  • Dark Spots by Visioface (Day 0, 14, 28)

  • Skin Barrier by TEWAMETER (Day 0,14,28)

  • Dermat evaluation on a 5-point ordinal scale would be used for the Even Skin Tone (Day 0, 14,28)

  • Dermat evaluation on a 5-point ordinal scale would be used for the Skin Texture (Day 0, 14,28)

  • Dermat evaluation on a 5-point ordinal scale would be used for the Smooth skin (Day 0, 14,28)

  • Visioscan Images( Day 0 and Day 28)

  • HD Imaging with DSLR (Day 0 and Day 28 )

  • Subject’s Self Assessments. (day 28 )

Subjects will be on study for up to 28 days. Screening & Assigning: Day 0 Follow-ups: on Day 0 and Day 14 EOT: Day 28

Test Product: Neutriderm Vitamin C Serum Dose: Gently use approx. 5-6 drops of the Vitamin C serum on the face twice a day for 4 weeks. Route of Administration: Topical

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 mild pigmented 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 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
  • 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 Skin Gloss

时间窗: At time T0, day 14 and day 28

2. change in Skin Pigmentation

时间窗: At time T0, day 14 and day 28

3. change in Skin Hydration

时间窗: At time T0, day 14 and day 28

4. change in Dark Spots

时间窗: At time T0, day 14 and day 28

5. change in TEWL

时间窗: At time T0, day 14 and day 28

6. Change in Dermat evaluation

时间窗: At time T0, day 14 and day 28

7. visioscan

时间窗: At time T0, day 14 and day 28

8. DSLR imaging

时间窗: At time T0, day 14 and day 28

次要结局

  • Not Applicable(Not Applicable)

研究者

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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