A clinical observational study to evaluate Safety and Efficacy of HSTF-022206 in Healthy Adult Subjects in reduction of facial dark spots.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Reduction in dark spots
研究概览
简要总结
An open-label, single-arm, single-centre clinical observational study to evaluate Safety and Efficacy of HSTF-022206 in Healthy Adult Subjects in adult human subjects from 18 to 55 years with facial dark spots. Subjects will be pre-screened by the study team. Subjects will be telephonically contacted by recruiting team prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) not to wear any facial make-up during study visit to facility. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits. ✓ Visit 1 (Day 1): Screening and Enrolled Day 1 ✓ Visit 2 (Day 7): Product usage Period, Evaluation Visit ✓ Visit 3 (Day 14): Product usage Period, Evaluation Visit ✓ Visit 4 (Day 28): Product usage Period End, End of the Study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 to 55 years (both inclusive) at the time of consent.
- •Sex: Healthy non-pregnant/non-lactating females and Males.
- •Subject has facial dark spots includes sun-tan, blemishes, sunspots, and age spots.
- •Female of childbearing potential must have a reported negative pregnancy during screening.
- •Subject is generally in good health.
- •Subject has not undergone any cosmetic procedures or any medication for the treatment of acne or facial dark spots 3 months prior to study enrolment and willing to forgo any treatment duration of the study.
排除标准
- •1.Subject has a history of allergy or sensitivity to the test treatment ingredients 2.Subject who has a history of allergy with products containing turmeric or any known ingredients.
- •Subject who has pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne, acne rosacea or any other) that could interfere with the subject selection and outcome of the study as determined by the Investigator.
结局指标
主要结局
1.Reduction in dark spots
时间窗: Day 1,Day 7,Day 14,Day 28
2.Improvement of PGA scoring
时间窗: Day 1,Day 7,Day 14,Day 28
3.Change in skin appearance
时间窗: Day 1,Day 7,Day 14,Day 28
4.Safety of skin
时间窗: Day 1,Day 7,Day 14,Day 28
次要结局
- To evaluate the product safety of skin by local intolerance(evaluation by investigator and occurrence AEs and SAEs.)