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Assessment of the primary skin irritation potential of Venusia Max lotion and cream: A controlled human patch test study
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Received: ,
Accepted: ,
How to cite this article: Gala M, Muchhala S, Dhanaki G, Sanghavi A, Kotak B. Assessment of the primary skin irritation potential of Venusia Max lotion and cream: A controlled human patch test study. CosmoDerma. 2026;6:64. doi: 10.25259/CSDM_9_2026
Abstract
Objectives:
This study evaluated the skin irritation potential of Venusia Max Cream and Venusia Max Lotion using a standardized human patch test in both normal and sensitive skin populations.
Materials and Methods:
In this single-center, non-randomized, single-blind, single-application, controlled study, approximately 0.04 g of cream and 0.04 g of lotion were applied occlusively on the backs of adult participants. Negative (0.9% isotonic saline) and positive (1% sodium lauryl sulfate) controls were included. Patches were removed after 24 h, and assessments were conducted at 48 and 72 h using the Draize scale. Participants with visible reactions were followed up after 1 week. Sensitive skin status was confirmed by the lactic acid sting test. Data were summarized using descriptive statistical methods.
Results:
Twenty-six participants (13 males, 13 females; mean age 30.88 ± 9.97 years), evenly divided into sensitive and normal skin groups, completed the study. At 48 h, mean cumulative irritation scores were 0.38 for Venusia Max Lotion and 0.27 for Venusia Max Cream; both further decreased at 72 h (0.23 and 0.04, respectively). All scores remained well below the irritancy threshold of 2.0. No adverse events or intolerances were observed in either normal or sensitive skin groups.
Conclusion:
Venusia Max Lotion and Cream were classified as “Non-Irritant” as per IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics (Third Revision) guidelines. Both formulations demonstrated low irritation scores in normal and sensitive skin populations under controlled patch test conditions, indicating good dermal tolerability. From a consumer perspective, the key advantage lies in achieving consistent skin comfort and barrier support through daily moisturization, made possible by a gentle, non-irritant formulation.
Keywords
Draize scale
Emollient formulation
Patch test
Sensitive skin
Venusia max
INTRODUCTION
Skin serves as the body’s primary protective barrier against environmental insults and is frequently exposed to chemicals, cosmetics, and other topical products.[1,2] The stratum corneum functions as a critical biophysical barrier indispensable for terrestrial viability, minimizing transepidermal water loss (TEWL) while concurrently shielding the host from a broad spectrum of external aggressors, including mechanical stressors, microbial invasion, and oxidative insults.[3] Topical exposure to cosmetic product ingredients may elicit a spectrum of cutaneous reactions, ranging from transient irritation to allergic contact responses. Clinically, dermatitis may manifest as erythema, edema, oozing, crusting, scaling, or, in some cases, vesiculation.[4,5] Notably, irritant contact dermatitis accounts for nearly 80% of all contact dermatitis cases resulting from direct chemical or physical insult to the skin barrier.[6,7]
Despite the intrinsic robustness of the cutaneous barrier, certain cosmetic xenobiotics can still permeate the stratum corneum and enter systemic circulation. The detection of hazardous contaminants, including heavy metals, nitrosamines, phenolic compounds, hydroquinone, and steroidal agents, has therefore elicited significant toxicological concern, given their potential for systemic bioactivity even at low-dose, chronic exposure.[8] Pooled data from seven countries in North America and Europe showed that about 6.8% (2066 out of 30,207) of people have allergic contact dermatitis from cosmetics.[9]
Within this toxicological context, the test formulations are enriched with a physiologically relevant blend of occlusive, humectant, and emollient agents designed to reinforce stratum corneum barrier function. The formulations typically incorporate key active ingredients such as glycerin (a potent hygroscopic humectant), Shea butter, mango butter, and aloe butter. These constituents are widely recognized for their favorable dermal tolerability profiles. Therefore, during the development of novel cosmetic formulations, it is essential to detect any dermal reactions suggestive of sensitization, particularly because cosmetic products are not expected to provoke allergic responses under normal use conditions. Among the established methodologies, the patch test remains one of the most widely accepted techniques for evaluating dermal tolerability and detecting the potential irritant effects of topical products.[6,10,11]
According to the Bureau of Indian Standards {IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics (Third Revision) guidelines}, patch testing provides a standardized procedure to identify irritant responses under controlled conditions and ensures reproducibility and ethical compliance of the results.[12]
Despite stringent regulatory frameworks, data gaps persist regarding the real-world tolerability of newly formulated cosmetic products in humans. Many formulations undergo stability and physicochemical testing; however, systematic human-based patch testing remains underutilized in early development. Moreover, regional variability in cosmetic use patterns, climate, and skin sensitivity underscores the need for locally relevant safety data that reflect the experiences of Indian consumers.
Given the growing consumer demand for dermatologically safe and irritation-free cosmetic products, patch testing plays a dual role in bridging product innovation and regulatory compliance while also generating evidence that builds dermatologists’ confidence in products for sensitive or chronic skin conditions. Therefore, this study was designed to evaluate the skin irritation potential of Venusia Max Lotion and Cream using human volunteer patch testing, in accordance with the IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics (Third Revision) guidelines. By including both normal and sensitive skin groups, this investigation not only addresses regulatory safety requirements but also provides meaningful insights into everyday usability, long-term tolerability, and consumer trust, all critical factors for the successful adoption of emollient formulations.
MATERIALS AND METHODS
Study design
This was a single-center, non-randomized, single-blinded, single-application, controlled study to assess the skin irritation of Venusia max lotion and cream (Dr. Reddy’s Laboratories Ltd., Hyderabad, India) using the Skin Irritation Test (Patch Test in Humans). The study was carried out at C.L.A.I.M.S. Pvt. Ltd., Andheri, Mumbai, under the supervision of a qualified dermatologist between June 19 and June 28, 2025. The protocol was reviewed, and the trial was approved on June 04, 2025, by the Independent Ethics Committee (ECR/245/ Indt/MH/2015/RR-22), C.L.A.I.M.S. Pvt. Ltd.
The study was conducted in compliance with the Protocol, Bureau of Indian standards guidelines {IS 4011: 2018 Methods of test for safety evaluation of cosmetics (Third Revision) guidelines}, Indian Council for Medical Research guidelines (2017) The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R3) Guideline for good clinical practice (GCP) (2016), good clinical laboratory practices, Declaration of Helsinki (Brazil, October 2013), and other applicable regulatory requirements. The study, including potential risks and benefits, was explained to the participants by the Investigator before screening for the study. The Investigator addressed all participant queries, and willing participants were given consent for the study.
As this was an exploratory dermal safety study, no formal randomization was performed. A fixed-site allocation approach was used to ensure consistent placement of test products and controls across participants. The evaluator assessing skin reactions was blinded to treatment allocation to minimize assessment bias.
Study population
This study included 26 participants (preferably an equal number of men and women) aged 18–65 years, with 50% having sensitive skin as determined by the lactic acid sting test. Participants with apparently healthy skin on the test area and Fitzpatrick skin types III–V were recruited. Participants who were included in the study were required to refrain from intense ultraviolet exposure and activities leading to excessive sweating or water contact (e.g., swimming, exercise, and sauna) during the study. Participants were not on any systemic or topical medications before or during the study. Pregnant or lactating women, individuals with scars, tattoos, excessive terminal hair on the test area, dermatological pathologies, known allergies to cosmetic products, chronic illnesses that could influence study outcomes, and those on treatments that could interfere with the study were excluded.
Treatment and follow-ups
There were two test products and positive and negative controls involved in this study. The test products were Venusia Max Lotion 0.04g (B. No BZD5120) and Venusia Max Cream 0.04 g (B. No BZD5121), and 0.04 mL of positive control 1% Sodium Lauryl Sulfate (SLS) (B. No 927850) and negative control 0.9% Isotonic saline solution (B. No 0925C006).
Patch testing was conducted on the upper back of all participants under controlled conditions. For the test products, approximately 0.04 g of each formulation was filled in different wells of standardized patch chambers and applied occlusively to the designated test sites. For control sites, filter papers dipped in 1% SLS (positive control) and 0.9% isotonic saline (negative control), each containing approximately 0.04 mL, were filled in different wells of the patch chambers. All patches were applied at Visit 1 (0 h) following study explanation, informed consent, and confirmation of eligibility through inclusion–exclusion assessment. The occlusion was maintained for 24 h, after which the patches were removed at Visit 2. Skin reactions at each site were clinically evaluated and scored according to the Draize scale at 48 h (Visit 3) and 72 h (Visit 4) after exposure to a test product or control. Participants exhibiting any visible reaction were reassessed after 1 week (Visit 5) to confirm complete recovery. In addition, representative photographs of patch-application areas were captured for documentation purposes.
Efficacy and safety measurements assessed and flow chart
The safety and efficacy measurements and the time points at which they were carried out are depicted in Table 1.
| V1 (0 h) |
V2 (24 h) |
V3 (48 h) |
V4 (72 h) |
V5-1 week (if applicable) |
|
|---|---|---|---|---|---|
| Explanation of trial procedures | X | - | - | - | - |
| Collection of signed informed consent | X | - | - | - | - |
| Demographic information | X | - | - | - | - |
| Medical history/prior treatments | X | - | - | - | - |
| Inclusion/exclusion criteria (clinical examination) | X | - | - | - | - |
| Application of patch | X | - | - | - | - |
| Patch removal | X | X | - | - | - |
| Concomitant treatments recording | X | X | X | X | X |
| Reading skin recording | - | - | X | X | X |
| Adverse event recording | X | X | X | X | X |
| Final report in Case Report Form/Logs | - | - | X | X | X |
Scoring
Scoring of the test area was done with the Draize scale, which evaluates erythema/dryness/wrinkles and edema on separate 0–4 scales as shown in Table 2.
| Erythema/dryness/wrinkles formation | Score | Oedema formation | Score |
|---|---|---|---|
| No reaction | 0 | No oedema | 0 |
| Very slight erythema/dryness with shiny appearance | 1 | Very slight edema (barely perceptible) | 1 |
| Slight erythema/dryness/wrinkles | 2 | Slight edema (edges of area well defined by definite raising) | 2 |
| Moderate erythema/dryness/wrinkles | 3 | Moderate edema (area raised∼1 mm) | 3 |
| Severe erythema/wrinkles/scales | 4 | Severe edema (raised >1 mm and extending beyond the area of exposure) | 4 |
Primary outcome
To evaluate the skin irritation reactions (erythema, edema, dryness, scaling, wrinkling), using the Draize scale.
Adverse effects (AEs)
Systemic and local AEs were monitored in all participants. Any treatment-emergent AEs were identified and treated accordingly.
Statistical/analytical plans
No formal sample size calculation was performed. A sample size of 26 participants was considered adequate for preliminary irritation assessment and is consistent with standard patch test studies evaluating dermal safety.
Descriptive statistics were used to summarize irritation scores. Continuous variables were expressed as mean ± standard deviation (SD). No inferential statistical comparisons were performed due to the exploratory nature of the study and the limited sample size. Irritation classification was based on predefined thresholds as per IS 4011:2018 guidelines.
Scoring methodology
Conclusions are based on IS 4011: 2018 methods of test for safety evaluation of cosmetics (Third Revision) guidelines (48-h scores): Mean scores ≤2.0/8.0 were classified as non-irritant, scores >2.0–4.0/8.0 as mildly irritant, and scores >4.0/8.0 as irritant.
RESULTS
Demographic characteristics
The study was completed with 26 participants. There were no dropouts or protocol deviations during the study. Among the 26 participants, the age ranged from 18 to 47 years, with an average of 30.88 years (SD = 9.97). The study included 13 men and 13 women. There were 13 participants identified as having sensitive skin and 13 participants with normal skin.
Product assessment criteria
At 48 h, the mean cumulative scores for Venusia Max Lotion and Venusia Max Cream were 0.38 and 0.27, respectively, which further decreased to 0.23 and 0.04 at 72 h. In comparison, the negative control (0.9% isotonic saline solution) demonstrated a score of 0.00 at both times, whereas the positive control (1% SLS) demonstrated markedly higher scores, decreasing from 3.04 at 48 h to 2.73 at 72 h [Figure 1].
As the mean cumulative scores for both test formulations remained below the predefined threshold value of 2, Venusia Max Lotion and Venusia Max Cream were classified as nonirritants, as per IS 4011: 2018 guidelines [Tables 3 and 4].
| Product | Mean score (A*) | Mean score (O*) | Mean score (A+O*) | Irritancy assessment |
|---|---|---|---|---|
| Venusia max lotion | 0.38 | 0.00 | 0.38 | Non-Irritant |
| Venusia max cream | 0.27 | 0.00 | 0.27 | Non-Irritant |
| 0.9% Isotonic saline-negative control | 0.00 | 0.00 | 0.00 | Non-Irritant |
| 1% sodium lauryl sulfate-positive control | 2.00 | 1.04 | 3.04 | Mildly Irritant |
| Product | Mean score (A*) | Mean score (O*) | Mean score (A+O*) | Irritancy assessment |
|---|---|---|---|---|
| Venusia max lotion | 0.23 | 0.00 | 0.23 | Non-irritant |
| Venusia max cream | 0.04 | 0.00 | 0.04 | Non-irritant |
| 0.9% isotonic saline-negative control | 0.00 | 0.00 | 0.00 | Non-irritant |
| 1% sodium lauryl sulfate-positive control | 1.85 | 0.88 | 2.73 | Mildly irritant |
Adverse events
There were no study-related adverse events or intolerances observed during the study.
DISCUSSION
This study was designed to evaluate the primary skin irritation potential of Venusia Max Lotion and Cream using a standardized human patch test in accordance with the IS 4011: 2018 guidelines. Both formulations were classified as non-irritants, with mean cumulative irritation scores well below the threshold of 2, at both 48- and 72-h following exposure, irrespective of normal or sensitive skin type. The negative control (0.9% saline) yielded a score of 0.00, whereas the positive control (1% SLS) demonstrated markedly higher scores, decreasing from 3.04 at 48 h to 2.73 at 72 h, supporting the validity and sensitivity of the study design. According to the Berger and Bowman grading system (<1 = non-irritant) and the primary irritation index thresholds proposed by Han et al. (0.38 and 0.27 = negligible irritant potential), the observed values confirm the test product classification as non-irritant.[13,14]
Similarly, a non-randomized controlled trial directly comparing Venusia Max Cream with negative saline and positive SLS controls in healthy adults (Fitzpatrick phototypes III–V) reported zero irritation scores for the test product and negative control, while the SLS-positive control showed marked irritancy (mean score, 2.60). Importantly, no adverse events or intolerances were observed, reinforcing the non-irritant nature of the formulation.[15]
Comparable human repeated insult patch test evaluations of Venusia Max Lotion further support these observations, consistently reporting mean cumulative irritation scores <2 with no positive responses during the challenge phases. Collectively, this body of evidence underscores the reproducibility of the non-irritant and hypoallergenic profiles of Venusia Max products across different study settings and methodologies.[16]
The favorable tolerability of Venusia Max formulations may be attributed to their emollient-rich and paraben, alcohol, mineral oil, and animal ingredients (PAMA)-free composition, which includes Shea butter, mango butter, aloe butter, and glycerin.
As a biocompatible humectant, glycerin helps corneocyte hydration and mitigates TEWL, effectively offsetting surfactant-related xerotic effects.[17,18] Consistent with this mechanism, clinical evaluations reported an absence of dryness among participants throughout the study.
Shea butter establishes a semi-occlusive lipid matrix that attenuates TEWL, thereby preserving stratum corneum hydration, enhancing barrier functional integrity, and reducing xerosis-related irritation. Consistent with evidence demonstrating that moisturizers significantly augment skin hydration and strengthen barrier performance, the incorporation of shea butter contributes to smoother, more resilient skin physiology.[19,20]
Mango butter, enriched with tocopherols, phytosterols, and triterpenes, exhibits strong anti-wrinkle, smoothing, and barrier-repair properties, supporting its suitability for sensitive-skin formulations. Its emollient action restores a naturally occlusive barrier and replenishes moisture, promoting soft, well-hydrated skin. These mechanistic effects align with our observation of a wrinkle score of zero.[21]
These ingredients are well recognized for their ability to support skin barrier integrity and reduce TEWL,[15] thereby lowering the risk of skin irritation. Previous research has confirmed that lipid-based moisturizers not only promote recovery following irritant-induced barrier disruption but also improve skin tolerance, particularly in individuals with heightened sensitivity.[22] Moreover, the absence of common irritants such as SLS, parabens, and mineral oils further contributes to the low irritancy potential, aligning these formulations with contemporary standards for safe dermocosmetic use.
These findings have potential implications for routine moisturization practices, particularly in individuals with sensitive skin. The observed low irritation profile suggests that such formulations may be suitable for use in maintaining skin hydration and supporting barrier function. However, these observations are based on acute irritation assessment under controlled conditions and should be interpreted within the context of the study design. From a consumer perspective, the ability to engage in consistent daily moisturization is of significant value, as it supports sustained barrier repair, optimizes skin hydration, and enhances overall dermal comfort. A non-irritant formulation, such as that demonstrated by Venusia Max Cream and Lotion, further enables this routine by minimizing the risk of irritation-related discontinuation and promoting long-term adherence to moisturization practices.[23,24]
In conclusion, the findings of this study demonstrate that Venusia Max Lotion and Cream were non-irritants under controlled patch test conditions. These results are consistent with existing evidence and contribute to the overall understanding of dermal tolerability of emollient formulations.
Strengths and limitations
The key strength of this study lies in its systematic demonstration of non-irritancy in both normal and sensitive skin groups using a standardized and reproducible patch-testing methodology. The evaluator-blinded, controlled design minimized variability and reduced assessment bias, thereby strengthening the reliability of outcome measures. The inclusion of a mixed volunteer pool representing both normal and objectively verified sensitive skin types, along with balanced gender distribution and Fitzpatrick phototype III–V, strengthens generalizability to the broader Indian population. Furthermore, rigorous ethical oversight, ICH-GCP compliance, and internal quality audits ensure high procedural reliability.
However, certain limitations should be considered while interpreting the findings. The study was conducted at a single center with a relatively small sample size, which may limit generalizability. The study design evaluated acute irritation following a single application under occlusive conditions and does not reflect repeated or long-term use under real-world conditions. In addition, no inferential statistical analysis was performed, which limits the ability to detect subtle differences between groups. Future studies with larger sample sizes, multicentric designs, and longer follow-up durations are warranted to further validate these findings.
CONCLUSION
Venusia Max Lotion and Cream demonstrated low irritation potential under controlled patch test conditions and were classified as non-irritants according to IS 4011:2018 guidelines. These findings were consistent across both normal and sensitive skin populations following single-application exposure.
Acknowledgment:
The authors thank the study subjects, principal investigators, and site (Site name: C.L.A.I.M.S. Pvt. Ltd.) staff.
Ethical approval:
The research/study approved by the Institutional Review Board at C.L.A.I.M.S. Pvt. Ltd, number ECR/245/Indt/MH/2015/RR-22, dated June 04, 2025. CTRI/2025/06/088700
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 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 funded by Dr. Reddy’s Laboratories Limited, Ameerpet, Hyderabad, Telangana, India.
References
- The impact of pollution and climate change on skin health: Mechanisms, protective strategies, and future directions. JAAD Rev. 2025;6:1-11.
- [CrossRef] [Google Scholar]
- Influences on skin and intrinsic aging: Biological, environmental, and therapeutic insights. J Cosmet Dermatol. 2025;24:e16688.
- [CrossRef] [PubMed] [Google Scholar]
- Skin barrier function: The interplay of physical, chemical, and immunologic properties. Cells. 2023;12:2745.
- [CrossRef] [PubMed] [Google Scholar]
- A review of contact dermatitis. Ann Allergy Asthma Immunol. 2021;126:32-9.
- [CrossRef] [PubMed] [Google Scholar]
- Allergic contact dermatitis revisited: A comprehensive review. JAAD Rev. 2025;4:92-103.
- [CrossRef] [Google Scholar]
- Absence of human skin irritation and allergenic potential after repeated patch applications of a lamellar moisturizer. J Cosmet Dermatol. 2019;18:377-82.
- [CrossRef] [PubMed] [Google Scholar]
- An overview of contact dermatitis: Occupational factors and preventive strategies. Int J Community Med Public Health. 2024;11:4113-8.
- [CrossRef] [Google Scholar]
- Prevalence and risk factors of cosmetic-induced adverse events: A systematic review and meta-analysis. J Appl Pharm Sci. 2024;14:252-63.
- [CrossRef] [Google Scholar]
- Clinical profile and photocontact sensitivity pattern in patients with cosmetic dermatitis: A prospective study. Indian J Dermatol Venereol Leprol. 2024;90:479-85.
- [CrossRef] [PubMed] [Google Scholar]
- Allergic contact dermatitis: Patch testing beyond the TRUE test. J Clin Aesthet Dermatol. 2010;3:36-41.
- [Google Scholar]
- Patch testing: Uses, systems, risks/benefits, and its role in managing the patient with contact dermatitis. Clin Dermatol. 2021;39:580-90.
- [CrossRef] [PubMed] [Google Scholar]
- Methods of Test for Safety Evaluation of Cosmetics. 2018. 3rd Revision. New Delhi: BIS; Available from: https://www.scribd.com/document/801366363/is-4011 [Last accessed on 2025 Dec 31]
- [Google Scholar]
- Human dermal safety testing for topical drug products. Presented at: U.S. Food and Drug Administration (FDA) Public Workshop: Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation 2018 Silver Spring, MD, USA. Available from: https://www.fda.gov/media/124984/download [Last accessed on 2025 Dec 15]
- [Google Scholar]
- ChemSkin reference chemical database for the development of an in vitro skin irritation test. Toxics. 2021;9:314.
- [CrossRef] [PubMed] [Google Scholar]
- Plant-based paraben-free moisturizer, Venusia max cream, is a nonirritant. CosmoDerma. 2022;2:25.
- [CrossRef] [Google Scholar]
- Evaluation of hypoallergenic and skin irritation potential of Venusia Ureka cream using human repeat insult patch test. Cosmoderma. 2025;5:81.
- [CrossRef] [Google Scholar]
- Glycerol and the skin: Holistic approach to its origin and functions. Br J Dermatol. 2008;159:23-34.
- [CrossRef] [PubMed] [Google Scholar]
- Moisturizer in patients with inflammatory skin diseases. Medicina (Kaunas). 2022;58:888.
- [CrossRef] [PubMed] [Google Scholar]
- The role of moisturizer containing anti-inflammatory on skin hydration in mild-moderate atopic dermatitis patients. Dermatol Res Pract. 2024;2024:3586393.
- [CrossRef] [PubMed] [Google Scholar]
- Investigation of the in vitro effects of shea butter on skin barrier function and hydration using analytical chemistry methodologies. Open Journal of Chemistry. 2025;5:1-7.
- [Google Scholar]
- Formulation and evaluation of exotic fat based cosmeceuticals for skin repair. Indian J Pharm Sci. 2008;70:539-42.
- [CrossRef] [PubMed] [Google Scholar]
- Effect of different moisturizers on SLS-irritated human skin. Contact Dermatitis. 2001;44:229-34.
- [CrossRef] [PubMed] [Google Scholar]
- Effects of Venusia Max Lotion on skin hydration and skin barrier in patients with dry skin. Cosmoderma. 2021;1:41.
- [CrossRef] [Google Scholar]
- Evaluation of comedogenic potential of a moisturizer venusia max lotion (PAMA free) IP Indian J Clin Exp Dermatol. 2022;8:28-31.
- [CrossRef] [Google Scholar]