A single arm clinical study to evaluate the efficacy of the Vitamin C in improving skin brightness and enhancing overall skin parameters
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.
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Skin Gloss by Glossymeter (T0, day 14 and day 28 )
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Skin Pigmentation by Mexameter Face (Melanin Index) (Day 0, 14, 28)
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Skin Hydration by Corneometer (T0, day14 and day 28)
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Dark Spots by Visioface (Day 0, 14, 28)
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Skin Barrier by TEWAMETER (Day 0,14,28)
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Dermat evaluation on a 5-point ordinal scale would be used for the Even Skin Tone (Day 0, 14,28)
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Dermat evaluation on a 5-point ordinal scale would be used for the Skin Texture (Day 0, 14,28)
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Dermat evaluation on a 5-point ordinal scale would be used for the Smooth skin (Day 0, 14,28)
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Visioscan Images( Day 0 and Day 28)
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HD Imaging with DSLR (Day 0 and Day 28 )
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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
Dr Robin Chugh
CCFT Laboratories
