Evaluation of skin safety of Venusia Acne Facewash for primary skin irritation using skin irritation test: Patch test in humans

Objectives: Face washes are an effective adjuvant in routine skincare for the management of acne vulgaris. However, prior assessment of the skin irritant potential of such formulations is essential to mitigate the risk of adverse dermatological effects. Venusia Acne Facewash is a product formulated for acne-prone skin. This study aimed to evaluate the primary skin irritation potential of Venusia Acne Facewash using a 24-h occlusive patch test in healthy human volunteers, as per IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics (Third Revision) guidelines. Material and Methods: This was a monocentric, non-randomized, single-blinded, single-application, controlled study conducted on healthy adult subjects aged between 18 and 65 years, with Fitzpatrick skin types III to V and having apparently healthy skin on the test area. The test product (Venusia Acne Facewash, diluted 8% w/w), positive control (1% sodium lauryl sulfate), and negative control (0.9% isotonic saline) were applied occlusively on the upper back for 24 h. Skin reactions, including erythema/dryness/wrinkles and edema, were assessed 48 h post-application using the Draize scale. Combined mean irritation scores were calculated for each sample. Results: A total of 26 subjects were enrolled, and 25 completed the study. One subject was discontinued due to unrelated systemic symptoms. Venusia Acne Facewash showed a combined mean irritation score of 1.08, classifying it as a non-irritant. The negative control showed no reaction (0.00), while the positive control showed a higher irritation score (3.04). All subjects showed complete recovery from any local reactions within 1 week. Conclusion: Venusia Acne Facewash demonstrated good dermal tolerance and was classified as non-irritant under the test conditions. These findings support its dermal safety and safe use as part of a regular skincare regimen, particularly for individuals seeking a gentle cleansing formulation.