A single blind clinical study to evaluate the effectiveness and Safety of Plum Vitamin C serum for skin brightening.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in percentage of consumers achieved a visible even tone skin/texture in 30 days.
研究概览
简要总结
Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed.Patients will be assigned to this study for 28 days in which Day 0 (Visit 1/Screening) done for screening purpose and handover the IP to the Subjects, and measure Melanin content by Mexameter, skin analysis by Spectrophotometer, Imagination of Dermis/ Epidermis, take HD picture by DSLR and Visio face scan/DJM scan. Additional on Day 14 or Visit 2 is required for doing subject assessment in which determination of the brightening of skin, dark spot intensity, tanning of skin, skin tone/texture, moisturizing level of skin and glowing of skin.Also, on the Day 14/ Visit 2 measure the physical characteristics which include texture of the test product, Spread-ability of the IP on the face and check the quickly absorption on the skin.On the Day 28/Visit 3/ Follow up, check the effect of IP by subject assessments and also any AE (Itching, Irritation and Burning sensation of the affected skin)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 34.00 Year(s)（—）
入选标准
- •Gender: Non-pregnant, non-lactating female aged between 18 to 34
- •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
- •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.
- •6.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 percentage of consumers achieved a visible even tone skin/texture in 30 days.
时间窗: Day14, Day 28
2. Change in percentage of volunteers achieved a visibly brighter skin in 30 days.
时间窗: Day14, Day 28
3. Change in percentage of volunteers achieved a glowing skin in 30 days.
时间窗: Day14, Day 28
4. Change in percentage of volunteers experienced visible reduction of dark spot/ hyperpigmentation in 30 days
时间窗: Day14, Day 28
5. Change in percentage of volunteers experienced how much percentage of improvement in skin tone/texture.
时间窗: Day14, Day 28
次要结局
- Not applicable(Not applicable)