Abstract
<p class="abstract"><strong>Background:</strong> Topical exposure to chemicals from cosmetics can lead to adverse skin effects or skin irritation. This study aimed to investigate the skin irritation and sensitizing potential of a moisturizer Venusia max lotion (paraben-free, alcohol-free, mineral oil-free, animal origin free (PAMA) free).</p><p class="abstract"><strong>Methods:</strong> In this single-center, non-randomized, observational study, skin irritation, and skin sensitization potential of a test product was assessed using the human repeat insult patch test (HRIPT) technique. Approximately 0.04 g of the test product and filter papers dipped in 0.9% isotonic saline solution (~0.04 ml of solution) were filled in different wells of patch chambers and applied occlusively, on the back of each participant. Scoring of the skin reactions in the induction phase and challenge phase was done using Draize and international contact dermatitis research group (ICDRG) scales respectively. Scores were compared to the baseline and the negative control (isotonic saline).<strong></strong></p><p class="abstract"><strong>Results:</strong> In total 234 participants (50 with sensitive skin), 224 and 221 participants completed the induction phase and challenge phase respectively. Scores for the induction phase for Venusia max lotion (PAMA free) and isotonic saline were 0.46 and 0.06 respectively. The mean cumulative score of erythema and oedema for Venusia max lotion (PAMA free) was below 2. For the challenge phase, none of the participants showed any positive reactions at any time point for test product and isotonic saline.</p><p class="abstract"><strong>Conclusions:</strong> Test product Venusia max lotion (PAMA free) found to be non-irritant and hypoallergenic. Thus, it can be used without fear of skin irritation or sensitization.</p>
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