CTRI/2022/04/041621已完成不适用
Evaluation of skin sensitization potential of investigational products by Human Repeat Insult Patch Test (HRIPT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the dermatological safety of the investigational products on healthy human subjects
研究概览
简要总结
Study will be conducted to assess the safety of the test products. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. For the selected subjects, the patch will be applied alternate days for 3 weeks. The assessment will be perfoemed for every 48 hrs once the patch is applied. Then there will be a rest phase of 2 weeks and then the patch will be applied and assessed for 72 hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects 18 to 65 years of age
- •Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.
- •The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.
- •Subjects with skin type (Normal: Oily: Combination: Dry in the ratio of 1:1:1:1), and sensitive skin (dry sensitive skin: normal sensitive skin in the ration 1:1)
- •Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study.
- •Subjects must have clear back.
- •They should not have any infection or allergy on the tested area.
- •They should have healthy skin on test area
- •Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures
- •Willingness to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study
- •Subjects with skin photo type III to V.
排除标准
- •Pregnant women/ Nursing mothers
- •Scars excessive terminal hair or tattoo on the studied area.
- •Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •Dermatological infection/pathology on the level of studied area
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
- •Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures
- •Chronic illness which may influence the outcome of the study.
- •Subject 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)
- •Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
- •Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision.
结局指标
主要结局
To evaluate the dermatological safety of the investigational products on healthy human subjects
时间窗: Approximately 6 weeks for each subject
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
To check the safety of the productsCTRI/2022/03/041526Marico Limited30
已完成
不适用
safety of the test product to be checkedCTRI/2023/11/059663HNL Business Services India Private Limited100
已完成
不适用
Safety Testing of cosmetic product by Patch testCTRI/2021/04/032587Freedom Fragrances24
已完成
不适用
Safety testing of cosmetic products by PIPT(Primary Irritation Patch Test)CTRI/2022/02/039947Arbro pharmaceutical Pvt Ltd24
已完成
不适用
Safety testing of cosmetic products by patch testCTRI/2021/12/038826Arbro pharmaceutical Pvt Ltd24