A Clinical study to evaluate the Anti-Pigmentation Activity of Terrai Hydrating Face Serum
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in Dark spots & Pigmentation
研究概览
简要总结
A single blind one arm study.
Each participant entering the trial will be assigned to a regimen of investigational product.
Day 0 (T0) - Baseline Measurements:
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Skin Gloss (Glossymeter): (0, 14, 28 days)
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Skin Lightness (Spectrophotometer): (T0, 14, 28 days)
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TEWL (Tewameter): (0, 14, 28 days)
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Skin Pigmentation (Melanin Index) (Mexameter): (0, 14, 28 days)
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Dark Spots (Visioface): (0, 14, 28 days)
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Wrinkle count : (0, 14, 28 days)
-
HD Imaging with DSLR: (0, 28 days)
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Visioscan Imaging: (0, 28 days)
Test Product: Terrai Hydrating Face Serum
Dose: :2-3 Drops twice in a day, apply sunscreen after 30 minutes
Route of Administration: Topical
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
入选标准
- •Gender: Male and Female Non-pregnant, non-lactating female aged between 25 and
- •Subject with Hyperpigmentation (Dark spots, uneven skin tone)
- •Subject willing to give written informed consent
- •Women of child bearing potential must have a negative urine pregnancy test.
- •Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
- •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
- •Volunteers with skin conditions such as eczema, psoriasis, etc
- •Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
- •Have open sore or open lesions in the treatment area
- •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
- •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 Dark spots & Pigmentation
时间窗: At Day0, Day 14, Day 28
2. Change in Wrinkle count
时间窗: At Day0, Day 14, Day 28
3. Change in Melanin Index
时间窗: At Day0, Day 14, Day 28
4. Change in skin lightness
时间窗: At Day0, Day 14, Day 28
5. Change in skin Elasticity
时间窗: At Day0, Day 14, Day 28
6. Change in TEWL
时间窗: At Day0, Day 14, Day 28
7. Change in skin hydration
时间窗: At Day0, Day 14, Day 28
次要结局
- Change in Hyperpigmentation(Change in Dark circles)
研究者
Dr Robin Chugh
CCFT Laboratories