+1 (202) 780-3397Research Article - Journal of Dermatology Research and Skin Care (2023) Volume 7, Issue 6
Evaluating the Dermal Safety and Skin Compatibility of Personal Care Cosmetic Products Formulated with Natural Ingredients: An In-Vivo Primary Irritation Patch Test Study.
Background: Cosmetic products have been widely used by the public for an extended period, emphasizing the high importance of ensuring their safety. Although cosmetic ingredients undergo skin irritation testing before entering the market, there is no obligatory mandate for producers to conduct final formulation testing.
Objective: The aim of this investigation was to assess the potential dermal irritation in individuals with diverse skin types when exposed to cosmetics and personal care formulations with natural ingredients. This evaluation utilized a single 24-hour application patch test method on healthy human subjects.
Methods: The dermal irritation potential of 26 personal care products of Vedistry Private Limited was tested following ethical principles and guidelines for Good Clinical Practice, IS 4011:2018 Methods of Test for Safety Evaluation of Cosmetics, CHD 25: Soaps and Other Surface-Active Agents Sectional Committee (first revision) and IS 13424:2001 Safety evaluation of bathing bars and toilet soaps. The products were applied on the subject’s back region i.e., between the scapula and waist. Application sites were evaluated for scoring the reaction, namely, erythema, dryness, wrinkles on a 0–4-point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours. The mean irritation score was computed through an excel-based calculation method.
Results: At both 30 minutes and 24 hours after removing the patches containing test products and controls, all 26 test products with a mean irritation score below 2.0 were determined to be non-irritating and safe for skin use. The negative control, showing a mean irritation score below 2.0, was confirmed as non-irritant. Conversely, the positive controls, which exhibited a mean irritation score surpassing 2.0, were identified as mild irritants at both the 30-minute and 24-hour assessments following patch removal. No subjects experienced serious adverse events or test product-related adverse event.
Conclusion: Vedistry's moha: Personal care product line, crafted with natural ingredients for both skin and hair care, adheres to dermatological safety standards. Following a 24-hour primary irritation patch test conducted under occlusion, these products are classified as non-irritating, skin-compatible, and safe for diverse skin types-ranging from oily and mixed to dry, normal, and sensitive.