Publication:

Evaluation of skin irritation and skin sensitization potential of Venusia sunscreen using human repeat insult patch test

Background Sunscreens are widely used for daily photoprotection, making evaluation of their dermatological safety essential. This study aimed to assess skin irritation and sensitization (hypoallergenic) potential of Venusia Sun Unseen (sunscreen) in healthy human participants.

Methods This single-centre, evaluator-blinded study using human repeat insult patch test (HRIPT). It was conducted in three phases: induction (21 days), rest (14 days) and challenge phase (4 days), with skin reactions in the induction and challenge phases graded using the Draize scale and International Contact Dermatitis Research Group (ICDRG) scale, respectively. Test product and a negative control (0.9% isotonic saline) were applied occlusively on the back of participants using patch chambers.

Results Out of 220 participants, 218 completed the study (mean age 38.8 years; 94.5% female). Among them, 64.2% had normal skin and 35.8% had sensitive skin. Venusia Sun Unseen was classified as non-irritant, with a mean cumulative Draize score of 0.21 (induction phase). Negative control showed a score of 0, confirming the absence of irritation. ICDRG assessments demonstrated predominantly negative responses with test product, with 176 participants exhibiting no reaction at 48 hours and any doubtful or weak reactions resolving by 96 hours (challenge phase). It showed no strong positive reactions at any time point, while negative control showed negative responses throughout the study. No adverse events (AEs) or serious AEs were reported.

Conclusions Venusia Sun Unseen was found to be non-irritant and hypoallergenic, with no clinically significant irritation or sensitization observed. It was well-tolerated, supporting its routine use for photoprotection.