Evaluation Of Dermatological Safety Of Test Products By Primary Irritation Patch Test Under 24 hrs Occlusion On Healthy Human Volunteers Of All Skin Types.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1.Number of subjects that showed no significant irritation.
研究概览
简要总结
The objective of the study is to assess the dermatological safety of the test products on healthy human subjects. This will be an open-label, non-randomized, monocentric, single-application, controlled clinical trial. Healthy adult volunteers will be selected according to specific inclusion and exclusion criteria. A total of 24 healthy adult participants, both male and female, aged between 18 and 65 years in a 1:1 ratio, will be tested with the test products intended for use on normal skin. The patch application will be evaluated based on the assessment criteria outlined in the appendices. References Related to Background of the Trial from Bureau of Indian Standards (BIS)- Methods of Test for Safety Evaluation of Cosmetics (IS 4011:2018), Third Revision
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Voluntary men and women ratio of 1:1 between 18 and 65 years.
- •2.Having healthy skin on test area as assessed by dermatological examination.
- •3.For whom the investigator considers that the compliance will be correct.
- •4.Subjects with normal, dry, oily and combination skin in approximately equal ratio.
- •5.Subjects cooperating is informed of the need and duration of the examination and ready to comply with protocol procedures.
- •6.Having a signed consent form.
- •7.Subjects’ willingness to avoid intense UV exposure on test site (sun or artificial UV) during the study.
- •8.Willingness to avoid excessive water contact (e.g. swimming) or activity which causes excessive sweating (e.g. exercise, sauna) during the study.
- •9.Having valid proof of identity and age.
- •10.Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).
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.
- •6.Chronic illness which may influence the outcome of the study.
- •7.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •8.Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.
结局指标
主要结局
1.Number of subjects that showed no significant irritation.
时间窗: Day 2 Day 3 and Day 9
2.Score of less than or equal to 2 on the Draize scale.
时间窗: Day 2 Day 3 and Day 9
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Sohandas Shetty
TrialGuna Private Limited