Awareness level regarding adverse reactions caused by cosmetic products among female patients: A cross‐sectional study

Cosmetics have become an integral part of our daily routine. In addition to causing a wide range of dermatological disorders, cosmetic preparations can also affect internal health. Men are less likely to be impacted than women.

or beauty products are primarily used to enhance glamour and beauty and are crucial to creating an impeccable public image.
These products have a significant impact on the skin and can be beneficial, ineffective, or harmful. Women are more affected than men because they tend to use more cosmetics, in amount as well as in frequency. [2][3][4] Women may also experiment with different types of products. Moreover, their skin is thinner as compared to men's.
Studies show that most people who use cosmetics are more concerned with the immediate positive effects on their appearance than with the long-term repercussions on their body. They assume beauty products to be risk-free and harmless to health. 5 Long-term use of cosmetic products may have adverse health consequences.
The chemical components in makeup products have been found to disrupt the endocrine system. 6 Ingredients including fragrances and preservatives can individually or in combination, lead to toxicity. 2,7 More than 10 000 ingredients can be found in cosmetics, and many of these have been related to various disorders like cancers developmental and reproductive impairment. Accordingly, US FDA, EU, ASEAN, Japan, and many other health regulatory agencies in the world have prohibited or restricted some of the ingredients for use in cosmetic products. 8 Adverse effects are on the rise, paralleling the increasing use of cosmetics, but without proportionate increase in awareness. Developing nations still lack adequate systems for reporting adverse effects. 9 The number of documented adverse cosmetic reactions is currently quite low, and this may be due to self-medication of mild to moderate skin reactions, rather than seeking medical help. According to the literature, promoting cosmetovigilance and awareness programs on use of cosmetic products can reduce negative outcomes. 10,11 The aim of the study was to assess the awareness level among female patients regarding adverse reactions caused by cosmetic products.

| Study area and period
The study was performed in the Dermatology department, Kasturba

| Study design
A cross-sectional study design was used to assess awareness levels regarding adverse reactions caused by cosmetic products among female patients.

| Ethics consideration
The study protocol was approved by the Ethical Review Committee (IEC No: 585/ 2020). CTRI approval was also taken for the study.

| Study population
All female patients who visit the dermatology outpatient department at KMC were the source population. All female patients who were selected by the sampling technique and gave their informed consent were considered the study population.

| Inclusion criteria
All female patients between the age group 18-60 who visit the dermatology outpatient department KMC during the study period and who gave their consent to participate in the study were included.

| Exclusion criteria
Questionnaire was in English language, patients who were not conversant with the language, and those with severe facial dermatoses and allergies were excluded from the study.

| Sample size determination
A non-probability sampling technique, the Convenience sampling methodology was selected. A sample size of 400 female patients was taken and calculated by using the estimation of proportionate formula.

| Data collection
Pilot tested, self-administered questionnaire was used for data collection. The questionnaire was created through a literature search. The questionnaire was divided into three sections. Part one covered the patients' general information (socio-demographic data). Part two dealt with the utilization pattern of products by the patients. The final section dealt with the adverse events caused by the use of the products. The information gathered from responders was kept strictly confidential.

| Variables
The dependent variables were self-reported adverse reactions and cosmetics utilization whereas the independent variables of the study include age, working status, occupation, and the number of cosmetics applied per day.

| Data processing, analyzing, and interpretation
The information gathered from the respondents was recorded and For categorical data, the chi-square test was used to assess the difference between groups. A p-value of 0.05 was considered statistically significant for statistical analysis.

| Socio-demographic results
A sample of 400 female patients was selected for the study. The age of the respondents ranged from 18 to 60 years. Out of 400 respondents, 126 (31.5%) respondents were of age 18-28 followed by 113 (28.25%) who were of age group 29-39. Two hundred and sixty two (65.5%) women were non-working whereas 138 (34.5%) were working women. (Table 1).

| Cosmetic utilization practices
Out of the 400 study participants, 395 (98.75%) women used cosmetic products. Among those, 126 women were aged between 18 and 28, years, 138 (34.5%) were working and 262 (65.5%) were nonworking women. The majority of non-working women (159 [39.75%]) stated that they do use cosmetics products regularly. Statistically significant difference was found between cosmetic use, age, and working status ( Table 1).
Among 395 participants who used cosmetics products, 364 used 1-3 cosmetic products per day. Most women (62%) stated that they did not consult a dermatologist before using the product.
However, 170 (43.03%) of the respondents had the habit of reading the label on the cosmetics containers (content, manufacturer details, safety, and storage instructions). More than half of the respondents (214 [54.75%]) did not follow the instructions given on the products; about three fourth (295) of the respondent were not aware of the presence of heavy metals in the cosmetics products.
About 357 (90.37%) respondents noted the expiry date of the products before using them. Few women had undergone sensitivity (104, 26%) and patch tests (97, 24.25%) before using the products, especially hair dye. Most women (378, 95.75%) were not aware of the cosmetovigilance system or method for reporting of adverse events.
The cosmetic use-related practices among the study patients are given in Table 2.
The most common was Talcum powder and compact powder in 321 respondents, followed by facial soaps and shampoo in 304 ( Figure 1). Sixty-one (15.25%) women consulted dermatologists for cosmetic-related problems. Forty-four women (71.42%) were prescribed medications, out of whom, 42 women had complete improvement. Thirteen out of 61 women had undergone product change after consulting a dermatologist and adverse events completely subsided in 12 of these women ( Table 3).

TA B L E 1
Respondents' socio-demographic characteristics and use of cosmetic products (n = 400).

| DISCUSS ION
The past two decades have seen a huge boom in the cosmetic industry, leading to the development of a wide variety of innovative products to hydrate, nourish, and soothe the skin and treat aging signs as well as inflammation. The Current net worth of cosmetics market is estimated to be approximately $20 billion. Beauty products are frequently used by women and may include dangerous ingredients. 12 Metals in cosmetics have the potential to remain in the body and be absorbed into the bloodstream, wherein they can affect multiple organs. To increase the consistency, appearance and quality of cosmetic products, preservatives, stabilizers, and mineral pigments are used. Some mineral pigments are given a higher sparkle by adding glitter and color. Any of these compounds have the potential to irritate, trigger allergic reactions, and impair human health. 13,14 In our study, the total number of cosmetics users was 395 (98.75%), the majority belonging to the age group of 18-28 years, which is comparable to the studies by Bilal et al. 10 and Getachew and Tewelde. 2 This is easily explained as younger women are more beauty and image conscious and may have a greater demand for cosmetic products as they are also expected by societal and cultural norms to look beautiful and blemish free. This study found that the percentage of non-working women consistently using cosmetics products was higher than that of working women. This is slightly paradoxical as we expect working women to present themselves with more care to the external world. But we contemplate that home bound women may be more beauty conscious than working women as they get relatively more time for personal grooming, and the need to present themselves at their best makes them use cosmetics regularly. Working women may not have the time or energy to regularly use cosmetic products. The majority of the women used a minimum of 1-3 products per day. This may be attributed to the hot and humid atmospheric condition existing in the selected study area which precludes the use of oily and creamy foundations and lotions.
In this study, adverse cosmetic events (ACEs) due to the use of skincare products were noted. Among 395 cosmetics users, 44% experienced adverse effects due to the use of cosmetic products.
The main cause for the increase in adverse events may be the use of multiple cosmetics simultaneously, which might increase the concentration of ingredients over the safe level which might lead to adverse events or increase the synergistic action of cosmetic products. 15 Another reason may be humidity of the study region, TA B L E 2 Cosmetics use-related practices among female patients of dermatology department KMC (n = 395).

Variables Categories Frequency Percentage
Per day use of cosmetics Maximum harm was caused by complexion skin care products.
Scalp hair and face were the most affected areas by cosmetics adverse events. Acne was the most common side effect associated with the use of cosmetics and affected about 15.25% women. The findings were similar to previous research, which also stated that the frequently reported body site was the hair and face (acne). 15,16 Acne is a common occurrence post cosmetic use and is attributed to occlusion of pilosebaceous orifices by oily or occlusive cosmetics.
Facial erythema often occurs secondary to irritant potential of various ingredients.
Nausea and headache experienced by a small proportion of women (1.25%) were brought on by the intense odor of the products.
The number of participants who consulted a dermatologist was 15%, which is quite less. This highlights the fact that most women consider cosmetics harmless and are least bothered about the occurrence of ACEs. Participants' low reporting of adverse events may be due to their inability to identify their problems and determine whether it was the result of the cosmetics they used. 10,16,17 Studies reveal that consumers underreport ACEs even though they may have suffered serious consequences in some cases. 11 Though there is lack of awareness regarding consulting health professionals, the measures taken by respondents like changing or discontinuing the cosmetic products were appropriate. Some women even initiated drug use, along with continuing the cosmetics in certain circumstances, which may have been an occasional scenario be recommended by the consultant. 11,18 But this should be strongly discouraged as the patient is not qualified enough to choose drugs and treatment for ACEs without the counsel of a qualified dermatologist.
Women in this study had the habit of reading the label (43.05%) and expiry date (90.75%). These are positive and laudable practices.
Many women (54.75%) did not follow the instruction given on the label, and this might have increased the chance for adverse events.
Consumers of cosmetics are strongly advised to adhere to some safety precautions. These include following hygiene measures, reading the ingredient lists on the labels, and choosing cosmetics with fewer ingredients. In general, it is up to the consumer to take the necessary precautions to get the most benefits from cosmetics. 16,19 As to the presence of harmful chemicals or heavy metals such as lead, arsenic, and mercury in cosmetics products, this study revealed that the majority of the females were not aware of the pres- Additionally, it has been discovered that it interferes with hormone function, acting as a probable endocrine disruptor that could harm an unborn child and worsen infertility.
Litner et al. proposed that every cosmetic product contains at least one, but often many, chemical substances. Hence, before a product was marketed to the general public, the manufacturer should be responsible for conducting a safety evaluation on their products. 11,21 Patch test and sensitivity test: In our study, 75% of women applied the cosmetics without undergoing any prior skin allergy test.
These data are similar to that reported by Getachew  This study found that around 95.75% of women are not aware of the cosmetovigilance system or reporting adverse events.
"Cosmetovigilance is a model of safety monitoring of cosmetics. It can be considered as one of the elements in public health activities." 22 This health policy is a legally acceptable way to collect information on the effectiveness of cosmetics and their components to lower the risks related to cosmetic use. 12,23 Beauty products should be used cautiously, and people should be educated on their proper use so as to reduce the adverse effects. 24 To promote positive changes in the production and marketing, industry as well as in consumption of cosmetic products by the general public, cosmetovigilance must be implemented globally. 12,23 The study is sure to impact our future patient consultations.
We are formulating a strategy whereby the patients will be actively asked about their cosmetic/cosmeceutical usage, and counseled regarding the consequences of indiscriminate use, and the side effects thereof. We are also planning to study further, the side effects related to cosmetics and cosmeceutical, especially sunscreens and hair dye, which is emerging as the main cause for allergic contact dermatitis and facial pigmentation. We are also planning to extend the study to males. We also plan to set up a cosmetovigilance center at the institution level.
This study has its limitations. The estimates of adverse events related to cosmetics were based on participant self-report, which was susceptible to recall bias and therefore result in underestimation.
Patients believed that there might not be a connection between the adverse events and cosmetic products as the cause. The fact that the questionnaire was in English rather than the local language may have impacted the accuracy of our study results. Incomplete data were not considered during the analysis. Males were not included in the study, which on retrospectively analysis, is a limitation.

| CON CLUS ION
Cosmetic use is a universal phenomenon, especially among females, irrespective of age or occupation, though young adults are more prone to using and experimenting with innovative and multiple products. Talcum powder and compact powder were the most commonly used products in our study. Scalp hair and face were the body sites most affected by adverse effects. Up to 44% women who use cosmetic products reported having at least one unfavorable event. The quantity and regularity of cosmetic product use were significant indicators of the possibility of adverse events. This implies the need to consider cosmetic product use-related safety concerns. The concept of cosmetovigilance can be promoted among cosmetic distributors, users, manufacturers, and other stakeholders in order to reduce the adverse events.

ACK N OWLED G M ENTS
We would like to thank Manipal Academy of Higher Education for the provision of all support. We would like to express our deepest gratitude to the study participants.

CO N FLI C T O F I NTE R E S T S TATE M E NT
The authors declare no conflicts of interest.

DATA AVA I L A B I L I T Y S TAT E M E N T
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

E TH I C S A PPROVA L
The study protocol was approved by the Ethical Review Committee Smitha S Prabhu https://orcid.org/0000-0002-2410-5208