OBJECTIVES:

Cosmetovigilance is an ongoing and systematic monitoring of the safety of the cosmetics. Skin-care products are used widely for the purpose of beautification, skin protection, self-care and for personal use and satisfaction. This shows the need for conducting a cosmetovigilance study among the skin-care products which can analyze, monitor and report various ACEs from skin-care products to the regulatory authority thereby creating an awareness.

METHODS:

A community based observational study was carried out in the Urban community of Bengaluru for a period of 7 months from October 2019 to March 2020. Data regarding the cosmetic use was collected using a pre-validated questionnaire, which mainly focused on socio-demographics, cosmetic utilization pattern, and a separate session for Adverse Cosmetic Events (ACEs) from skin-care products. Causality Assessment was then carried out to find out the causal relationship between the skin-care product used and the adverse event occurred.

RESULTS:

A total of 678 ACEs was reported. It was most commonly reported with face wash (12.2%), followed by lipstick (9.8%), face cream (9.8%), moisturizer (7.1%), soap (7.1%) and kajal (7.1%). Most commonly reported ACEs includes pimples (20.8%), dermatitis (17.7%), skin dryness (12.7%) and burning sensation (8.8.%). Others include allergic sneezing, oily skin, skin peeling, watery eyes, chapped lips, dry lips, etc. Majority of the study population used various remedies to treat the ACEs (63.4%), only 17.4% of them visited physician. Causality Assessment showed that it was unlikely (8.4%), questionable (22.6%), excluded (1.0%), likely (59.0%) and very likely (9.0%).

CONCLUSIONS:

The factors like using adulterated products, not following the proper instructions for use played a crucial role in the development of ACEs. Lack of awareness on ACEs and low literacy rate resulted in under-reporting of ACEs to the regulatory authority. Creating awareness among the consumers will help to minimise the incidence of occurrence of ACEs.