Dermatological Safety and Skin Compatibility Evaluation of Test Product following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997)
This is single-centre, evaluator blinded study in healthy human subjects. single 48-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 48hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total four visits in this study. Visit 01 (Day01):Screening, Enrolment and Patch Application, Visit 02 (Day 03):Patch Removal \& 30 ± 5 min irritation scoring upon patch removal. Visit 03 (Day 04): 24 (± 2 hour)irritation scoring (Day 04)Visit 05: At 48±2 hours Irritation Scoring
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
26
Dose: 0.1 ml of sample solution Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours.
To evaluate the dermatological safety of the test products assessed by 48-hour patch test under complete occlusion condition.
Dermatological reactions will be evaluated using the 48-hour patch test method under complete occlusion. Assessments will be performed to detect any skin irritation, erythema, or other local reactions at the application site.
Time frame: 30 ± 5 minutes post patch removal (Day 03), 24 ± 2 hours post patch removal (Day 04), and 48 ± 2 hours post patch removal (Day 05).
Skin Safety Evaluation by assessing Change in Transepidermal Water Loss (TEWL) at the Application Site
Transepidermal Water Loss (TEWL) at the site of product application will be measured using the TEWAMeter TM Hex to assess the impact of the investigational product on skin barrier function
Time frame: at baseline, 30 mins and 24 hours post patch removal
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