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

INTRODUCTION

Acne vulgaris is a chronic inflammatory condition of the pilosebaceous unit, which includes the hair follicle, hair shaft, and sebaceous gland.^[1] It is the most common skin condition worldwide, affecting approximately 20.5% of the global population, with one in five adults (aged between 25 and 39 years) experiencing acne.^[2] In India, acne affects approximately 72% of both children and adolescents, while around 27% of cases are seen in adults, indicating a high prevalence in younger age groups.^[3,4] It is characterized by a variety of lesions ranging from non-inflammatory, superficial comedones (blackheads or whiteheads) to inflammatory, deeper lesions such as papules, pustules, nodules, and cysts, often leading to scarring and hyperpigmentation.^[5]

In adult persistent acne, genetic and familial factors are primary contributors; poor hygiene can exacerbate acne.^[6-8] Therefore, incorporating mild, gentle, and effective cleansers such as face washes in a person’s skincare regimen is an important component of acne management.

Harsh skincare products containing irritants such as sulfates, parabens, synthetic fragrances, or artificial colors can damage the skin barrier, leading to irritation, dryness, or allergic reactions such as contact dermatitis.^[9-11] In contrast, gentle, non-irritating facewashes enriched with vitamins, antioxidants, and hydrating ingredients help cleanse the skin effectively, without disrupting the skin’s natural moisture barrier, making them valuable in acne management, especially for individuals with sensitive or acne-prone skin^[12,13]

Given the widespread and frequent use of facewashes, especially on sensitive skin, these products must undergo rigorous safety and dermatological testing before commercialization, particularly to evaluate skin tolerability. Various testing methods (including patch test) are commonly used to assess skin irritation and evaluate the safety of personal care and cosmetic products.^[14,15] A suitable facewash should cleanse the skin without stripping away the lipids, proteins, and the beneficial microbiome that maintains the skin integrity.^[16]

Venusia Acne Facewash, developed by Dr. Reddy’s Laboratories, is a cosmetic cleanser formulated for acne-prone skin. It contains active ingredients such as salicylic acid and glycolic acid, which provide exfoliating benefits.^[17,18] In addition, it contains aloe vera, which has been shown to suppress the hyperproliferation of Propionibacterium acnes and aid in acne improvement,^[19] and niacinamide, which exhibits anti-inflammatory properties, regulates sebum production, and supports skin barrier function.^[20] Considering its intended daily use on sensitive skin, it is critical to establish its dermal safety profile, despite its promising use in acne. This study aims to assess the dermal safety of Venusia Acne Facewash through a patch test, to determine its suitability as a daily cosmetic adjuvant for acne-prone skin.

MATERIAL AND METHODS

Application procedure

During screening visit 1, patch chambers containing the test product, positive control, and negative control were occlusively applied to designated areas on the subject’s back, with an occlusion period of 24 h. In Visit 2 (24 h post-application), patches were removed. Visit 3 (48 h from initial application) involved clinical evaluation of the test sites under standardized artificial daylight conditions. Subjects showing any visible reactions at 48 h were called for Visit 4 (1-week post-application) to confirm resolution of symptoms. Representative photographs were taken from 10 subjects for documentation. The brief chronology of events is depicted in Figure 1.

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Figure 1:

Flowchart of the study, explaining events in chronological order.

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RESULTS

Between June 11, 2025, and June 20, 2025, 26 subjects were recruited, wherein one subject dropped out due to unrelated systemic symptoms. Data were analyzed for 25 subjects [Figure 1].

Skin irritation assessment and mean score analysis

The Venusia Acne Facewash showed a mean erythema score of 0.84, a mean edema score of 0.24, and a combined irritation score of 1.08, classifying it as a non-irritant based on the predefined category (≤2.0/8.0) [Table 2]. The negative control (0.9% isotonic saline) showed no irritation. The positive control (1% SLS) demonstrated higher irritancy, with a combined mean score of 3.04. A photographic representation of two subjects at the time of patch application and scoring is provided in Figure 2.

Table 2: Combined mean scores of subjects at 48 h (visit 3).

Products	Mean score (A)	Mean score (O)	Mean score (A+O)	Irritancy assessment
Venusia Acne Facewash (n=25)	0.84	0.24	1.08	NonIrritant
0.9% Isotonic Saline (Negative Control) (n=25)	0.00	0.00	0.00	Non irritant
1% SLS (Positive Control) (n=25)	1.96	1.08	3.04	Mildly irritant

Erythema/Dryness/Wrinkles=(A), Edema=O, Erythema/Dryness/Wrinkles+Edema=A + O. SLS: Sodium lauryl sulfate

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Figure 2:

Representative photographs of subjects at the time of patch application and scoring.

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DISCUSSION

Many environmental pollutants, cosmetic residues, and skin lipids are not water-soluble and therefore cannot be effectively removed by rinsing with plain water alone.^[21] Cleansing plays a critical role in maintaining skin hygiene, particularly for individuals with acne-prone or sensitive skin.^[21] Cleansers function as surface-active agents that reduce surface tension, facilitating the removal of sebum, dirt, microbes, makeup, and desquamated skin cells.^[21,22] However, not all cleansers are equally skin-friendly. Traditional soap-based products often contain harsh surfactants that can disrupt the skin barrier, leading to irritation, dryness, erythema, or itching.^[22] While the choice of cleanser may be less critical for individuals with healthy skin, it becomes particularly important in dermatological conditions such as acne vulgaris, atopic dermatitis, rosacea, and sensitive skin syndromes.^[21]

Mild, moisturizing formulations are preferred, as they offer cleansing benefits while helping to maintain the skin’s hydration and viscoelastic properties.^[22] For acne-prone skin, the goal of cleansing is to gently eliminate surface debris, excess oil, and sweat without provoking inflammation or exacerbating skin dryness.^[21] Thus, products should be non- irritating, non-comedogenic, non-acnegenic, non-allergenic, and compatible with concurrent topical treatments.^[21] the goal of cleansing is to gently eliminate surface debris, excess oil, and sweat without provoking inflammation or exacerbating skin dryness.^[21] Thus, products should be non- irritating, non-comedogenic, non-acnegenic, non-allergenic, and compatible with concurrent topical treatments.^[21]

Skin irritation is one of the most common local adverse effects associated with dermally applied personal care products.^[15] In addition to irritation, cosmetics can also cause allergic reactions and acneiform eruptions in sensitive individuals.^[15] Therefore, evaluating the irritation and sensitization potential of cosmetic formulations is an essential step in ensuring their safety before widespread use.^[15]

The current study evaluated the dermal safety and irritation potential of Venusia Acne Facewash using a standardized patch test in healthy adult volunteers. The results demonstrate that the product has a low irritation potential, with a mean irritation score of 1.08, thereby classifying it as non-irritant based on predefined criteria. This finding is clinically relevant, especially considering the intended daily use of the product to maintain healthy skin, and may additionally benefit individuals with sensitive, acne-prone skin. The absence of any AEs related to the product further supports its tolerability and safety.

The favorable tolerability profile of Venusia Acne Facewash observed in this study may be attributed to its well-balanced formulation, combining therapeutic efficacy with skin barrier protection. The product contains a range of active ingredients commonly used in acne management, including salicylic acid, niacinamide, glycolic acid, and aloe vera. Salicylic acid provides comedolytic and exfoliating effects that help prevent pore blockages.^[23] Niacinamide complements this action by reducing inflammation, improving skin texture, and minimizing post-inflammatory hyperpigmentation.^[23] The formulation also includes zinc-pyrrolidone carboxylic acid (PCA), known for its sebum-regulating and anti- inflammatory properties, which can help reduce the number of inflammatory lesions in acne-prone skin.^[24,25]

Notably, the use of encapsulated salicylic acid may contribute to the low irritation observed in this study by enabling controlled release, thereby maintaining exfoliating and broad-spectrum antimicrobial activity while minimizing skin sensitivity. Additional components, such as glycolic acid, support exfoliation and improve skin texture.^[23] Hydrating and barrier-supporting agents, including allantoin, oat extract, aloe vera, and a hyaluronic acid–ceramide complex, play a crucial role in maintaining skin moisture levels and reducing transepidermal water loss, which are essential in minimizing irritation and supporting overall skin health. Importantly, the cleanser is formulated with mild, sulfate-free surfactants such as decyl glucoside, cocamidopropyl betaine, and sodium lauroyl sarcosinate. These agents are known for their gentle cleansing action and are less likely to disrupt the skin barrier compared to traditional soap-based surfactants. The inclusion of multivitamin beads containing Vitamins A, C, E, B3, and B5 further enhances the formulation by offering antioxidant protection and supporting skin repair processes. Together, these ingredients create a synergistic formulation that not only targets acne-related concerns but also promotes barrier integrity and reduces the risk of irritation, consistent with the non-irritant classification observed in this study. The clinical relevance of such a gentle formulation lies in its suitability for daily use across different skin types, including sensitive and acne-prone skin. By cleansing effectively without disrupting skin hydration, Venusia Acne Facewash demonstrates good overall tolerability, making it appropriate for regular use as part of an acne management regimen and for maintaining healthy skin.

This study has several strengths. It employed a standardized patch testing method in accordance with IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics (Third Revision) guidelines, using both positive and negative controls, contributing to its methodological soundness. The use of human subjects, validated scoring systems, and photographic records enhanced the credibility and consistency of the results. Nonetheless, certain limitations should be acknowledged. The study population comprised healthy individuals under controlled conditions, which may limit generalizability. The small sample size, while adequate for initial safety assessment, also restricts generalizability. In addition, it did not evaluate potential skin reactions from repeated or long-term use, as this was a single-application study. Future studies, including human repeat insult patch tests or long-term trials in acne patients, are needed to confirm the product’s safety and efficacy in routine use.

CONCLUSION

Venusia Acne Facewash was found to be non-irritating under controlled test conditions, with no adverse skin reactions or intolerance reported. These findings support its dermal safety and safe use as part of a regular skincare regimen. Further clinical evaluation in the target population may help substantiate its suitability for routine use, particularly for individuals with acne-prone skin seeking a gentle cleansing formulation.