A Clinical Study to Evaluate the Skin Brightening activity of Vitamin C Microneedle Serum Shot
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
To evaluate the trial assigned to a regimen of investigational product
-
Skin gloss-
-
Anti PIgmentation
Gender: Male and female aged between18 to 50. Volunteers-36
Test Product: Vitamin C Microneedle Serum Shot Dose: 2-4 drops twice in a day 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 50.00 Year(s)（—）
入选标准
- •Gender: Male and female aged between18 to
- •Subject with dull skin.
- •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 T0min, T1hrs, T14days
2. Change in Skin Gloss
时间窗: At T0min, T1hrs, T14days
3. Change in Melanin Index
时间窗: At T0min, T1hrs, T14days
4. Change in skin lightness
时间窗: At T0min, T1hrs, T14days
5. Change in skin firmness
时间窗: At T0min, T1hrs, T14days
6. Change in skin hydration
时间窗: At T0min, T1hrs, T14days
7. Change in TEWL
时间窗: At T0min, T1hrs, T14days
8. Change in Smoothness
时间窗: At T0min, T1hrs, T14days
次要结局
- SGA(At T14days)
研究者
Dr Robin chugh
CCFT Laboratories