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
Dose: 1×1 cm of each Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1)post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application
NovoBliss Research Private Limited
Ahmedabad, India
To evaluate the dermatological safety of the test products
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 as per draize scale
Time frame: Post patch removal of 30 minutes, 24 hours & 168 hours
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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