CTRI/2022/08/044805已完成Unknown
“Dermatological safety evaluation of VIP SNORE CARE OIL by Primary Irritation Patch test within 24hours application on all types of healthy human skin
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Score of less than or equal to 2 on the Draize scale
研究概览
简要总结
clinical study was initiated for estimation of the overall safety of test products by PIPT within 24 hours of application on healthy skin types. 24 healthy female and male (1:1) subjects of age group 35 to 60 Years have to be recruited. There are test products and one Negative control and Positive control. There are 5 visits andthe total duration of the study is 8 days. Subject’s Self-Assessment on skin irritation (baseline assessment for burning, itching, and stinging).Dermatologist’s Visual assessment as per Draize scale scoring system (for Erythema and Oedema) will be done
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy Men and women volunteers are chosen in ratio of 1:1 aged > 35 and < 60years.10% of the sample size, are chosen such that who are having a snoring issue while sleeping.
- •2.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure.
- •3.Having healthy skin on test area as assessed by dermatological examination and don’t have history of allergy.
- •4.Subjects who are compliant with the study.
排除标准
- •1.Pregnant/nursing mothers.
- •2.Scars, excessive terminal hair, or tattoo on the studied area.
- •3.Dermatological infection/pathology on level of studied area.
- •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
结局指标
主要结局
Score of less than or equal to 2 on the Draize scale
时间窗: Day 0,1,2,3,4,5
Number of subjects that showed no significant irritation.
时间窗: Day 0,1,2,3,4,5
次要结局
- NA(NA)
研究者
研究点 (1)
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