CTRI/2017/05/008582
Completed
未知
Evaluation of dermatological safety of investigational products by primary irritation patch test on subjects with sensitive skin
ITC Limited ITC Life Sciences Technology Centre0 sites35 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Limited ITC Life Sciences Technology Centre
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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. Baumannââ?¬•s skin type questionnaire
- •5\.Subject identified to have sensitive skin basis dermatologistââ?¬•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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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