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Evaluation of the skin irritation potential of Venusia Glo face wash using human patch test
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Received: ,
Accepted: ,
How to cite this article: Gala M, Muchhala S, Bhureddy S, Kumbhar P, Sanghvi A, Kotak B. Evaluation of the skin irritation potential of Venusia Glo face wash using human patch test. CosmoDerma. 2026;6:56. doi: 10.25259/CSDM_230_2025
Abstract
Objectives:
The objective of the study is to assess the skin irritation potential of Venusia Glo face wash using a standard patch test.
Materials and Methods:
This was a monocentric, single-blind, controlled study conducted in healthy men and women. Approximately 0.04 mL of 8% diluted test product (Venusia Glo face wash), 1% sodium lauryl sulfate (positive control), and 0.9% isotonic saline (negative control) were applied occlusively on the upper back using patch chambers for 24 h. Reactions were assessed 24 h after patch removal (i.e., at 48 h post-application) using the Draize scoring scale, which evaluates c on a 0–4 scale, with outcomes expressed as the sum of A and O scores (A+O) for final irritation grading.
Results:
Twenty-six participants were enrolled, and 25 completed the study (13 with sensitive skin and 12 with normal skin, as determined by the lactic acid sting test). The combined mean A+O score was 1.52 for the test product (Venusia Glo face wash), corresponding to a non-irritant response on the Draize scale, 3.04 for the positive control, and 0.00 for the negative control. No adverse events were reported during the study period.
Conclusion:
Venusia Glo face wash demonstrated a non-irritant profile under standardized IS 4011:2018 methods of test for safety evaluation of cosmetics (third revision) guidelines, patch test conditions, and was dermatologically safe for both normal and sensitive skin types, supporting its suitability and tolerability for routine daily use.
Keywords
Allergy
Draize scale
Dryness
Edema
Erythema
Irritancy
Patch test
INTRODUCTION
Skin is the outermost organ of the human body and serves as a vital barrier between the internal milieu and the external environment.[1] It protects against excessive transepidermal water loss and reduces the penetration of external substances into the body. This barrier function is primarily attributed to the stratum corneum, the uppermost layer of the epidermis.[2,3] In the modern era, cosmetic and personal care products have become integral to daily routines, with nearly 90% of individuals using at least one such product every day.[4] The appearance of facial skin is important for both health and aesthetics; therefore, a variety of facial cleansers are widely used.[5]
The primary purpose of most facial cleansers is to remove sebum, particulate matter, and impurities from the face. However, some formulations contain surfactants or other components that may disrupt epidermal lipids or proteins, leading to dryness, irritation, or compromised barrier function.[6,7] The type and concentration of surfactants play a major role in determining their potential to cause irritation.[8] Surfactants can act as irritants by solubilizing intercellular lipids and altering the structural integrity of the stratum corneum.[9] The severity of irritation depends on the nature and concentration of the substance and the duration of exposure. Clinically, irritation is characterized by erythema, edema, and occasionally, vesiculation. Persistent or repeated exposure may lead to irritant contact dermatitis, while prolonged barrier compromise can also predispose individuals to allergic contact dermatitis.[10,11] Therefore,assessing the irritation potential of cosmetic products is essential for ensuring consumer safety.
The standard human patch test, also referred to as the primary skin irritation test, involves a 24-h occlusive application of the test product (Venusia Glo face wash) on the back, followed by evaluation of erythema and edema using the Draize scale. Given the widespread use of facial cleansers, especially on sensitive skin, it is important to ensure their dermatological safety and tolerability. Accordingly, the present study aimed to assess the skin irritation potential of Venusia Glo face wash in healthy adults, including both normal and sensitive skin types, using a standardized human patch test in accordance with IS 4011:2018 methods of test for safety evaluation of cosmetics (third revision) guidelines.[12]
MATERIALS AND METHODS
Study design
This was a monocentric, non-randomized, single-blinded, single-application, controlled study conducted to evaluate the primary skin irritation potential of Venusia Glo face wash using a patch test. The study was conducted in compliance with applicable regulatory guidelines and was approved by the Independent Ethics Committee of C.L.A.I.M.S. Pvt. Ltd (ECR/245/Indt/MH/2015/RR-22). Written informed consent was obtained from all participants before enrolment.
Study population
The study included 26 participants (men and women) aged 18–65 years. The lactic acid sting test was used to determine skin sensitivity. Participants with Fitzpatrick skin types III–V and having apparently healthy skin on the test area were enrolled. All participants were required to be compliant, cooperative, and well-informed about the study requirements and examination procedures. They were instructed to refrain from intense ultraviolet exposure (sunlight or artificial sources) and from activities involving water contact or profuse sweating (e.g., swimming, exercise, or sauna) on the test site during the study period. Pregnant or lactating women, athletes, and individuals with a history of excessive sweating, scars, excessive terminal hair, or tattoos on the test area were excluded. Participants with dermatological issues (e.g., allergy to cosmetic products, raw materials, or hair dyes), systemic or cutaneous diseases, chronic illnesses, or those receiving any systemic or topical medical treatment that could interfere with study results were also excluded.
Study intervention and follow-up
The study involved a test product (Venusia Glo face wash), 1% sodium lauryl sulfate (SLS) as the positive control, and 0.9% isotonic saline solution as the negative control. The test product (Venusia Glo face wash) was diluted to 8% w/w in distilled water, and filter papers were soaked in approximately 0.04 mL of this solution and placed in the patch chamber wells. A similar procedure was followed for the positive and negative controls, each placed in separate wells. Trained clinical research associates applied the patches occlusively to the back of each participant at visit 1 for 24 h. At visit 2, patches were removed, and skin reactions were assessed under constant artificial daylight. The test sites were scored 24 h after patch removal at visit 3. Participants showing reactions were recalled for a follow-up visit 4 1 week later to confirm recovery.
Scoring criteria
Scoring of the test site was performed using the Draize Scale, which evaluates reactions such as erythema and dryness/wrinkling, and edema, each on a 0–4 point scale [Table 1]. The analysis was based on the combined mean irritation score recorded 24 h after patch removal, calculated using the following formula:
| Score | Indications | |
|---|---|---|
| Erythema/Dryness/Wrinkles | Edema | |
| 0 | No reaction | No reaction |
| 1 | Very slight erythema/dryness with shiny appearance | Very slight edema |
| 2 | Slight erythema/dryness/wrinkles | Slight edema |
| 3 | Moderate erythema/dryness/wrinkles | Moderate edema |
| 4 | Severe erythema/dryness/wrinkles | Severe edema |
Mean Score for Irritation = Total score (Erythema + Edema) for each sample/Total number. of subjects
Safety evaluation
Safety evaluation was conducted in accordance with the IS 4011: 2018 methods of test for safety evaluation of cosmetics (third revision) guidelines, wherein a mean score value up to 2.0/8.0 was classified as non-irritant; >2.0/8.0–4.0/8.0 as mildly irritant; and >4.0/8.0 as irritant.
Sample size
No formal sample size calculation was performed, as this study was conducted as a safety assessment in accordance with regulatory guidance. According to the IS 4011:2018 methods of test for safety evaluation of cosmetics (third revision) guidelines, a sample size of 24 subjects is generally recommended for such evaluations.[12] To account for potential dropouts, a total of 26 subjects were enrolled in the study.
RESULTS
Baseline characteristics
A total of 26 participants were enrolled in the study, of whom 25 completed it. One participant discontinued due to an adverse event that was unrelated to the test product (Venusia Glo face wash). The age of the participants varied from 18 to 54 years, with an average age of 31.56 years. The study comprised 13 male and 12 female participants. Based on the lactic acid sting test, 13 participants were classified as having sensitive skin and 12 as having normal skin [Table 2].
| Parameters | |||||
|---|---|---|---|---|---|
| Total number of participants-25 | Gender | Skin type | |||
| Mean age (years) | 31.56 | ||||
| SD* | 12.15 | Male | 13 | Sensitive | 13 |
| Range | 18.00–54.00 | Female | 12 | Normal | 12 |
Safety evaluation
The combined mean score for erythema/dryness/wrinkles (A) and edema (O) was 1.52 for the test product (Venusia Glo face wash). Based on the irritation-response ranges defined in IS 4011:2018 methods of test for safety evaluation of cosmetics (third revision) guidelines, this score falls within the non-irritant category. The positive control showed a score of 3.04, corresponding to a mildly irritant reaction, while the negative control had a score of 0.00, confirming a non-irritant response [Figure 1].
Adverse events
One participant experienced fever, throat infection, and nausea during the study; however, this event was deemed unrelated to the test product (Venusia Glo face wash), and the participant was withdrawn from further assessments. No adverse events were reported among the remaining 25 participants.
DISCUSSION
The present study was conducted to evaluate the primary skin irritation potential of Venusia Glo face wash through a controlled, single-blinded patch test, in accordance with established cosmetic assessment guidelines.
The inclusion of participants with both sensitive and normal skin types enhances the generalizability of the findings to a broader population. The primary endpoint, skin irritation assessed 48 h post-application using the Draize scoring method, indicated that Venusia Glo face wash had a combined mean irritation score of 1.52. This value lies within the non-irritant category as per IS 4011:2018 methods of test for safety evaluation of cosmetics (third revision) guidelines, which classifies scores ≤2.0 as non-irritant. In contrast, the positive control (1% SLS) produced a higher mean score of 3.04, indicating mild irritation and confirming test sensitivity, while the negative control (0.9% saline) yielded 0.00, suggesting it was non-irritant and validating specificity.
No adverse dermatological events were observed among the 25 participants who completed the study, supporting the product’s favorable safety profile. One unrelated systemic event (fever and throat infection) was excluded from analysis.
The non-irritant outcome is consistent with the known dermatological safety profiles of the formulation’s active constituents. Alpha arbutin, a hydroquinone derivative with melanin-inhibitory action, is recognized for its excellent cutaneous tolerability compared with hydroquinone.[13] Glycolic acid has been shown to be effective and safe at low concentrations, with 1% w/w used in the Venusia Glo face wash, providing gentle exfoliation to improve hyperpigmentation and acne.[14,15] Niacinamide (vitamin B3) improves barrier integrity, reduces inflammation, and enhances skin resilience against irritants.[16] Phenoxyethanol, a broad-spectrum preservative, is regarded as safe up to a maximum concentration of 1% w/w (concentration used in Venusia Glo face wash).[17] The synergistic combination of these mild, pH-balanced actives likely contributed to the favorable dermal compatibility observed in both normal and sensitive-skin participants.
These findings also have practical implications for real-world use. Patch-test performance under exaggerated occlusive conditions indicates a low likelihood of irritation during routine daily application. Since the study included both normal and sensitive Indian skin types, the results support the product’s suitability for diverse Indian skin profiles and climatic conditions such as heat, humidity, and pollution, which can increase susceptibility to irritation. This further supports regular use of the product to maintain skin cleanliness, preserve barrier function, and prevent the accumulation of pollutants.
Overall, the findings confirm that Venusia Glo face wash is dermatologically safe and non-irritant under controlled patch-test conditions. These results position the product as dermatologist-tested and clinically validated for sensitive skin, supporting its everyday safety for regular consumer use. The absence of irritation even under occlusive, exaggerated exposure conditions reinforces the formulation’s dermal compatibility and positions it as a reliable choice for individuals with sensitive or reactive skin. These results also align with existing literature supporting the tolerability of syndet-based and pH-balanced formulations for daily use in Indian consumers with diverse skin types.[18,19] Further large-scale or long-term usage studies may strengthen evidence on cumulative tolerability and extended safety in real-world conditions.
CONCLUSION
The test product, Venusia Glo Face Wash, was dermatologically evaluated in a mixed population comprising around participants with sensitive skin (assessed by the lactic acid sting test) and normal skin, in accordance with IS 4011:2018 methods of test for safety evaluation of cosmetics (third revision) guidelines. The results indicated that the formulation was non-irritant, confirming its dermatological safety for use on both normal and sensitive skin types.
Ethical approval:
The research/study was approved by the Independent Ethics Committee at C.L.A.I.M.S. Pvt. Ltd. number ECR/245/Indt/MH/2015/RR-22, dated April 30, 2025.
Declaration of patient consent:
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given consent for their images and other clinical information to be reported in the journal. The patient understands that the patient’s names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Conflicts of interest:
All authors are employees of Dr. Reddy’s Laboratories Ltd.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: This research was sponsored by Dr Reddy’s Laboratories Limited, Hyderabad 500016, India.
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