Assessment of primary skin irritation potential of Venusia cleanser: a human patch test study
DOI:
https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20261096Keywords:
Human patch test, Non-irritant cleanser, Sensitive skin dermal safety, Topical formulationAbstract
Background: This study aimed to evaluate the skin irritation potential of Venusia Cleanser using a standardized human patch test, with particularly in individuals with sensitive skin.
Methods: A monocentric, single-blind, controlled study was conducted in accordance with IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics (Third Revision) and ICH-GCP guidelines. Healthy adults aged 18–65 years were enrolled, with 50% having sensitive skin based on the lactic acid sting test. Venusia Cleanser (8% dilution), 0.9% saline (negative control), and 1% sodium lauryl sulfate (SLS, positive control) were applied on the upper back for 24 hrs using a patch test. Patches were applied at Visit 1 and removed after 24 hrs at Visit 2. Draize scoring was done at 48 hours, with a 1-week follow-up to confirm recovery.
Results: Of the 26 participants, 25 completed the study (mean age 31.6 years; 13 males, 12 females; 13 with sensitive skin). At 48 hours, Venusia Cleanser (8% dilution) demonstrated a mean irritation score of 1.12, well below the IS 4011:2018 threshold of 2.0, confirming its non-irritancy. The positive control (1% SLS) showed marked irritancy (mean score 3.04), while saline (mean score 0.00) produced no reaction. No delayed reactions occurred, and the formulation was well tolerated in both the sensitive and normal skin groups.
Conclusions: Venusia Cleanser was demonstrated to be safe, well-tolerated, and non-irritant for sensitive skin. These findings reinforce its suitability for daily-use cleansers, particularly for gentle cleansing that helps maintain skin barrier integrity while minimizing irritation risk.
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