To Check Dermatological Safety of Test Products by 24 Hours Patch Testing
This is single center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion \|Semi occlusion \|Open patch for at least 24 hours (+ 2 hours). Study can be conducted in multiple groups. Safety will be assessed throughout the study by monitoring of adverse events. Subject's back i.e. between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
26
0.04 gm of each Test Products along with positive control (1% SLS) and negative controls will be applied on the back of subjects i.e. between the scapula and waist through finn chamber patch.
NovoBliss Research
Ahmedabad, Gujarat, India
To evaluate the dermatological safety of the test products by 24 Hours Patch Test
Dermatological safety of the test products by 24 Hours Patch Test will be evaluated by 0: No reaction and 4 Severe Reaction
Time frame: Irritation Scoring at T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if needed
Safety of the skin
To evaluate the Safety of the skin by visual dermatological assessment by 0: No reaction and 4 Severe Reaction
Time frame: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required
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