Evaluation of dermatological safety of patch investigational products by primary irritation patch test on subjects with sensitive skin

ITC Limited ITC Life Sciences Technology Centre0 个研究点目标入组 24 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1. Healthy male and female subjects in the age group of 18-55 years (both age inclusive)
•2. Subjects in good general health
•3. Subjects with Fitzpatrick skin type III to V
•4.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. BaumannÃ¢â?¬•s skin type questionnaire
•5.Subject identified to have sensitive skin basis dermatologistÃ¢â?¬•s assessment of skin with fine texture and closeness of blood vessels
•to the surface
•6.Subjects willing to give a voluntary written informed consent
•7. Subjects willing to maintain the test patches in designated positions for 24 hours
•8. Subjects having not participated in a similar investigation in the past eight weeks
•9. Subjects willing to come for regular follow up visits
•10. Subjects ready to follow instructions during the study period
•11. Subjects without any open wounds, cuts, abrasions, irritation symptoms

•1. Subjects with a present condition of allergic response to any cosmetic product
•2. Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study
•3. Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy)
•4. Subjects with cutaneous disease that could interfere with the study results
•5. Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness
•6. Subjects participating in any other cosmetic or therapeutic trial

发起方

ITC Limited ITC Life Sciences Technology Centre