Evaluation of skin irritation and hypoallergenic potential of Venusia Cleanser using the human repeat insult patch test

Objectives: The objective of the study is to evaluate the dermatological safety, tolerability, and hypoallergenic potential of Venusia Cleanser using the human repeat insult patch test (HRIPT). Materials and Methods: A single-center, evaluator-blinded HRIPT was conducted on 220 healthy adults aged 18–65 years, including participants with sensitive skin identified through the lactic acid sting test. The test product (1% diluted Venusia Cleanser) and a negative control (0.9% isotonic saline) were applied occlusively on the participant’s back in three phases: Induction (nine 24 h applications), rest (14 days), and challenge (single 24 h application). Skin reactions were assessed using the Draize scale during induction and the International Contact Dermatitis Research Group scale during challenge. Safety and sensitization potential were evaluated qualitatively. Results: Of 220 participants recruited, 218 participants completed the study. 36% ( n = 78) were confirmed to have sensitive skin. During the induction phase, the mean cumulative irritation score for Venusia Cleanser was 0.08, significantly below the threshold of 2.0, which defines non-irritant status according to Bureau of Indian Standards - Indian Standard 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics (Third Revision) guidelines. Throughout the challenge phase, no strong positive or irritant reactions were observed at any time point. Only a few participants experienced transient, minor, doubtful reactions at 48 h, which resolved quickly without any lasting effects. No adverse events or safety concerns were reported during the entire study period. Conclusion: Venusia Cleanser demonstrated a non-irritant and hypoallergenic profile under HRIPT conditions, supporting its safe repeated use, including in individuals with sensitive skin. Being a single-center study, the findings may limit the generalizability of the results to broader and more diverse populations.