Abstract
Objectives To ensure that the marketed product is irritant-free, extensive premarket clinical testing of cosmetic products is necessary. Therefore, the present study evaluated the skin irritation reactions of the test product Venusia Max Cream-Paraben-free using a patch test. Material and methods This single group, blinded, controlled trial was conducted to compare our test product with negative saline and positive SLS control in healthy human subjects aged between 18 and 53 years (mean age of 30.93 years) having Fitzpatrick skin phototype classification III-V. During an initial phase, a patch dipped in test product, negative and positive control were applied under occlusion to the upper arm of participants and removed after 24 hours. Clinical evaluation of skin reactions (erythema, edema, dryness, and scaling wrinkling) in the area of the test product, negative and positive control after 24 hours of patch removal and then were scored based on the Draize scale. Results A total of 30 subjects were initiated and completed the study. Scoring for skin irritation (erythema/dryness/wrinkles/edema) of the subjects were evaluated based on Draize’s scale between test product, positive, and negative control. The combined mean score, i.e., of erythema/dryness/wrinkles, and edema was 0.00 in test product and negative control whereas 2.60 in the positive control. No adverse events or intolerances were reported due to the test product. Conclusion Venusia Max Cream-Paraben-free was dermatologically tested and found to be nonirritant.
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