Evaluation of skin irritation and skin sensitization potential of Venusia max lotion (paraben-free, alcohol-free, mineral oil-free, animal origin free) using human repeat insult patch test

Monil Y. N. Gala; Snehal S. Muchhala; Sujeet N. Charugulla; Rahul Rathod; Amey Mane; Sucheta Pandit; Alok R. Samal; Anup A. Choudhury

doi:10.18203/issn.2455-4529.IntJResDermatol20214907

Authors

Monil Y. N. Gala Department of Medical Affairs, Dr. Reddy’s Laboratories Ltd., Hyderabad, India http://orcid.org/0000-0002-9466-3301
Snehal S. Muchhala Department of Medical Affairs, Dr Reddy’s Laboratories Ltd., Hyderabad, India
Sujeet N. Charugulla Department of Medical Affairs, Dr Reddy’s Laboratories Ltd., Hyderabad, India
Rahul Rathod Department of Medical Affairs, Dr Reddy’s Laboratories Ltd., Hyderabad, India.
Amey Mane Department of Medical Affairs, Dr Reddy’s Laboratories Ltd., Hyderabad, India
Sucheta Pandit Department of Medical Affairs, Dr Reddy’s Laboratories Ltd., Hyderabad, India
Alok R. Samal Department of Formulation Research and Development, Dr Reddy’s Laboratories Ltd., Hyderabad, India.
Anup A. Choudhury Department of Formulation Research and Development, Dr Reddy’s Laboratories Ltd., Hyderabad, India.

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20214907

Keywords:

Moisturizer, Allergic contact dermatitis, Human repeat insult patch test, Irritants, Skin sensitization

Abstract

Background: Topical exposure to chemicals from cosmetics can lead to adverse skin effects or skin irritation. This study aimed to investigate the skin irritation and sensitizing potential of a moisturizer Venusia max lotion (paraben-free, alcohol-free, mineral oil-free, animal origin free (PAMA) free).

Methods: In this single-center, non-randomized, observational study, skin irritation, and skin sensitization potential of a test product was assessed using the human repeat insult patch test (HRIPT) technique. Approximately 0.04 g of the test product and filter papers dipped in 0.9% isotonic saline solution (~0.04 ml of solution) were filled in different wells of patch chambers and applied occlusively, on the back of each participant. Scoring of the skin reactions in the induction phase and challenge phase was done using Draize and international contact dermatitis research group (ICDRG) scales respectively. Scores were compared to the baseline and the negative control (isotonic saline).

Results: In total 234 participants (50 with sensitive skin), 224 and 221 participants completed the induction phase and challenge phase respectively. Scores for the induction phase for Venusia max lotion (PAMA free) and isotonic saline were 0.46 and 0.06 respectively. The mean cumulative score of erythema and oedema for Venusia max lotion (PAMA free) was below 2. For the challenge phase, none of the participants showed any positive reactions at any time point for test product and isotonic saline.

Conclusions: Test product Venusia max lotion (PAMA free) found to be non-irritant and hypoallergenic. Thus, it can be used without fear of skin irritation or sensitization.

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Author Biography

Monil Y. N. Gala, Department of Medical Affairs, Dr. Reddy’s Laboratories Ltd., Hyderabad, India

Medical Advisor

References

Xu S, Kwa M, Lohman ME, Evers-Meltzer R, Silverberg JI. Consumer Preferences, Product Characteristics, and Potentially Allergenic Ingredients in Best-selling Moisturizers. JAMA Dermatol. 2017;153:1099-105.

Purnamawati S, Indrastuti N, Danarti R, Saefudin T. The Role of Moisturizers in Addressing Various Kinds of Dermatitis: A Review. Clin Med Res. 2017;15:75-87.

Goh CL, Abad‐Casintahan F, Aw DC, Baba R, Chan LC, Hung NT, et al. South‐East Asia study alliance guidelines on the management of acne vulgaris in South‐East Asian patients. J Dermatol. 2015;42:945-53.

Kubba R, Bajaj AK, Thappa DM, Sharma R, Vedamurthy M, Dhar S, et al. Indian Acne Alliance (IAA). Acne in India: guidelines for management - IAA consensus document. Indian J Dermatol Venereol Leprol. 2009;75:1-62.

Chularojanamontri L, Tuchinda P, Kulthanan K, Pongparit K. Moisturizers for Acne: What are their Constituents? J Clin Aesthet Dermatol. 2014;7:36-44.

Zirwas MJ, Stechschulte SA. Moisturizer allergy: diagnosis and management. J Clin Aesthet Dermatol. 2008;1:38-44.

Held E. So moisturizers may cause trouble! Int J Dermatol. 2001;40:12-3.

Goel S, Shetty VH, Eram H, Babu AM. Study of the clinical pattern of contact dermatitis over the face and its correlation with patch testing. Int J Res Dermatol. 2019;5:350-6.

Johansen JD, Aalto‐Korte K, Agner T, Andersen KE, Bircher A, Bruze M, et al. European Society of Contact Dermatitis guideline for diagnostic patch testing–recommendations on best practice. Contact Dermatitis. 2015;73:195-221.

Farage MA, Maibach HI, Andersen KE, Lachapelle JM, Kern P, Ryan C, et al. Historical perspective on the use of visual grading scales in evaluating skin irritation and sensitization. Contact Dermatitis. 2011;65:65-75.

Dall'oglio F, Tedeschi A, Fabbrocini G, Veraldi S, Picardo M, Micali G. Cosmetics for acne: indications and recommendations for an evidence-based approach. G Ital Dermatol Venereol. 2015;150:1-11.

Loden M. Do moisturizers work? J Cosmet Dermatol. 2003;2:141-9.

Kumar P, Paulose R. Patch testing in suspected allergic contact dermatitis to cosmetics. Dermatol Res Pract. 2014;695387.

Cohen SR, Cárdenas-de la Garza JA, Dekker P, Haidari W, Chisolm SS, Taylor SL, et al. Allergic Contact Dermatitis Secondary to Moisturizers. J Cutan Med Surg. 2020;24:350-9.

McNamee PM, Api AM, Basketter DA, Frank Gerberick G, Gilpin DA, Hall BM, et al. A review of critical factors in the conduct and interpretation of the human repeat insult patch test. Regul Toxicol Pharmacol. 2008;52:24-34.

Nisbet SJ. Absence of human skin irritation and allergenic potential after repeated patch applications of a lamellar moisturizer. J Cosmet Dermatol. 2019;18:377-82.