Prevalence of Tuberculosis in Workers from the Department of Huila, Colombia

Introduction

Tuberculosis is an infectious disease that usually mainly affects the lungs and is caused by a bacterium (Mycobacterium tuberculosis), which is transmitted from patients with active lung disease through the air [1]. Tuberculosis is currently considered a public health problem worldwide, a re-emerging infectious disease [2], attributable to the high burden of disease, due to the costs it has for the health system, and other aspects, including bacterial resistance, the efficient mechanism of airborne transmission from person to person, and their ability to develop a chronic, disabling and lethal disease, especially in vulnerable and immunosuppressed people. In Colombia there is a surveillance system and a legal framework for the care, prevention, diagnosis, control and treatment of tuberculosis, within the legal framework built by the Ministry of Health and Social Protection is the Comprehensive Health Care Policy (PAIS), for the integral routes of health care, in its risk group of infectious diseases according to resolution 3202 of 2016[3]. The Single Regulatory Decree of the health and social protection sector 780 of 2016 defines the health regimes to which citizens belong in Colombia, dividing them mainly into a contributory and subsidized regime, which implies simply people with the ability to pay (contributory) and people subsidized by the system (subsidized), considers a risk factor for the occurrence of Tuberculosis, implying the determinants of health that generate inequalities by themselves, adversely affecting the most vulnerable population[4], that is, with greater social fragility, within which their work activity and socioeconomic status are included, recognizing that it is a disease associated with poverty and certain living conditions of the individual.

The World Health Organization defines the healthy work environment as: “one in which workers and managers collaborate in a process of continuous improvement to promote and protect the health, safety and well-being of workers and the sustainability of the work environment”[5] based on health and well-being indicators, related to the physical environment, psychosocial and cultural environment. This definition determines the conception of each of the occupations and implies conditions in which the worker performs, recovering the importance in the characterization and quantification of the prevalence of Tuberculosis, compared to the occupations reported in the workers of the department of Huila, considering that the population most affected by the disease is the economically active [6]. The report of occupations in our country is based on the International Uniform Classification of Occupations (ISCO-08). Given the limited availability of studies related to Tuberculosis in the work environment in the department of Huila, the prevalence of tuberculosis was determined between 2012 and 2017, evidencing the direct relationship of public health in occupational safety and health, participating in the analysis of exposure to agents that may cause tuberculosis in the workplace, with the collection and analysis of data, which generates timely, valid and reliable information, allowing decisions to be made regarding the measures of prevention, control and surveillance of the disease in the different actors of the health and labor system.

Methodology

A descriptive cross-sectional study was carried out, which allowed to determine the prevalence of tuberculosis between 2012 and 2017 and the distribution in each municipality of the department of Huila and the different socioeconomic conditions, such as the variables of age, gender, occupation, area of residence, ethnicity, type of social security regime, selecting those municipalities that had cases at least in a study period, selected from secondary sources (Table 1), obtaining the population of each municipality by age groups from the information available on the DANE website and the data on confirmed cases of tuberculosis reported in SIVIGILA during the period studied. The calculation of the fees, measures and percentage change are described below: - Crude rate: is the division of the number of reported cases of Tuberculosis among the population over 15 years for each corresponding year, multiplying by 100,000. - Adjusted rate: the direct method of rate adjustment was used, taking the Colombian population as the reference population. The specific crude rate of age and sex was multiplied by the Colombian population of the corresponding group (the age groups that were taken are: 15 to 44 years, 45 to 64 years and 65 and over years), the adjusted rates of all age groups in men and women were added, the result obtained was divided between the population over 15 years of both sexes. Finally, the rates were divided by quartiles being Q4 is the municipality with the worst rate, Q3 worst intermediate rate, Q2 best intermediate rate and Q1 is the best Rate.

Table 1: Description of information collected by secondary sources.

Note: Source: own elaboration

Measures based on ranges: The quotient was calculated:

Difference of extreme adjusted rates by quartiles making the previous ordering of each variable of the worst morbidity rate in the municipalities of the department during the years of study.

Extreme - Percentage variability of the adjusted rates in the extreme years of tuberculosis morbidity in the municipalities, between the initial and final period analyzed:

The analysis of the behavior of health and sociodemographic variables over time was performed with the use of Excel 2010 software, and IBM SPSS Statistics 21. This study was based on the very main ethic of beneficence, non-maleficence, autonomy, and justice, promulgated in the Nuremberg Codes and the Declaration of Hel sinki, according to resolution number 8430 of 1993, this research was considered risk-free.

Results

Table 2 shows a decrease in the tuberculosis morbidity rate in 2017 (28.81 per 100,000 people over 15 years of age) of 5.6% compared to 2012. 5.4% of the municipalities of the department, which were with the worst rates (quartile 4) of morbidity due to Tuberculosis during the 6 years of study were Neiva and Campo Alegre and were present with the worst morbidity rates at least in 5 years of study the municipalities of Agrado and Rivera. As for the municipalities that were with the best rates (quartile 1) at least in 5 years of study were the municipalities of Nátaga and Paicol; and 19% of the municipalities presented the best rates of morbidity due to tuberculosis in 4 years of the analyzed period, such as Altamira, Elías, Hobo, Oporapa, Tarqui, Teruel and Yaguará. In Q2 are the municipalities with the best intermediate rate and in Q3 are the municipalities with the worst intermediate rate.

Table 2: Adjusted rates of tuberculosis morbidity in the department of Huila.

Note: Quartile 1- Q1, quartile 2- Q2, quartile 3- Q3 and Quartile 4- Q4.

Source: own elaboration.

Table 3: Occupations related to Tuberculosis morbidity in the department of Huila.

Note: Source: own elaboration.

Table 3 describes the first 10 occupations that were related in the diagnosis of people over 15 years of age with tuberculosis, such as: farmers, agricultural, forestry and fishing workers with 9.9%, in second place other workers of personal services to individuals, not classified under other headings with 4%, in third place other non-university postsecondary technicians and commercial and administrative assistants with 2.8%, in fourth place are unskilled service workers (except domestic and related personnel) with 1.3%, in fifth place vehicle drivers and mobile heavy equipment operators with 1.2%, in sixth place unskilled workers in mining, construction, manufacturing and transport with 1.1%, in seventh place are street vendors with 1%, in the eighth and ninth place are with 0.9% office employees, officers and operators of the extractive industry and the tenth place are home sellers. It should be clarified that 68.7% of the people who presented tuberculosis during the study period were not classified under any occupation code.

In 2012, the municipality with the highest rate of tuberculosis was Neiva (78.4 per 100,000 inhabitants over 15 years of age), where the work carried out by infected people were non-university post-secondary technicians, commercial and administrative assistants, followed by vehicle drivers and mobile heavy equipment operators. In 2013 the municipality with the highest rate of tuberculosis was Altamira, (140.2 per 100,000 inhabitants over 15 years old), highlighting their work as non-university post-secondary technicians, commercial assistants, administrative assistants, and street vendors. In 2014 the municipality with the highest rate of tuberculosis was Neiva (67.5 per 100,000 inhabitants over 15 years of age), the work performed by infected people was that of unskilled workers in mining, construction, manufacturing, and transport, followed by street vendors. In 2015, the municipality with the highest rate of tuberculosis was El Agrado (43.2 per 100,000 inhabitants over 15 years of age), not relating the occupational classification of people diagnosed. In 2016, the municipality with the highest rate of tuberculosis was Rivera (111.4 per 100,000 inhabitants over 15 years of age), where the work carried out by infected people were farmers, workers, agricultural, forestry and fishing workers, followed by vehicle drivers and mobile heavy equipment operators. In 2017 the municipality with the largest, the rate of tuberculosis was Neiva (80.4 per 100,000 inhabitants over the age of 15), where the work performed by infected persons were vehicle drivers, mobile heavy equipment operators, office workers and unskilled service workers (except domestic and related personnel). The cases of tuberculosis analyzed in the study period were presented in 79.4% in the municipal capital, 7.1% in populated centers and 13.5% in the dispersed rural area; in 2012 the municipality with the highest rate of tuberculosis was Neiva, where 96% of the cases occurred in the capital and 3% in the population center. For 2013 the highest rate was in Altamira, where there is no difference between the municipal seat and the rural area. In 2014 the highest rate was in Neiva, where 96% of the cases occurred in the head and 2% in the rural area. For 2015 the highest rate was in Agrado, where the total of the cases that were presented belong to the municipal capital. In 2016, the highest rate was for Rivera, where 48% of the cases were in the rural area and 43% in the municipal capital.

In 2017, the municipality with the highest rate of tuberculosis was Neiva, where 95% of the cases belong to the municipal seat and 2% to the rural area. 63.6% of the reported cases with tuberculosis belong to the subsidized regime, 24.9% contributory regime, 2.3% special regime, 1.6% exception regime and 7.6% are poor uninsured people. In 2012 the municipality with the highest rate of tuberculosis was Neiva, where 53.3% of cases are insured under the subsidized regime and 31.3% of cases are insured under the contributory regime. For 2013 the highest rate was in Altamira, where all cases were insured to the contributory regime. In 2014 the highest rate was in Neiva, where 57.8% of cases are insured in the subsidized regime and 29.5% in the contributory regime. For 2015 the highest rate was in Agrado, where the total of the cases belonged to the subsidized regime. In 2016, the highest rate was in Rivera, where 43.5% of the cases are in the subsidized regime and 21.7% are uninsured people. In 2017, the municipality with the highest rate of tuberculosis was Neiva, where 57.5% of the cases were in the subsidized regime and 31.9% of the cases were in the contributory regime.

For the department, 0.8% of the cases diagnosed with tuberculosis were indigenous, and 60% were reported to be farmers, agricultural, forestry and fishing workers; 0.2% of the cases in the department were mulattoes and Afro-Colombians, where the type of work they performed was not classified; 0.2% of the cases in the department were ROM and Gitanos, where 33% worked as farmers, workers and agricultural, forestry and fishing workers; 1% of the cases in the department were Raizales and the rest are classified as others. Table 4 presents an analysis of variability of adjusted TB morbidity rates between 2012 – 2017, observing the changes which reflects tuberculosis in the period; the negative value indicates an increase in morbidity in the years analyzed, and the positive values indicate a decrease in morbidity. There was a decrease in tuberculosis morbidity of 9.8%, where 54% of the municipalities positively helped this indicator, and the municipalities that contributed a negative variability increasing their tuberculosis rate above 50% were Algeciras (-761%), Timaná (-483.9%), Colombia (-378.5%), Tello (-329.5%), Rivera (-139.1%), Baraya (-84.4%), Aipe (-82.7%) and Acevedo (-53.1%). Data in NA indicate that no cases occurred in the extreme years 2012 and 2017.

Table 5 presents the measures based on range (ratio and difference of extreme rates) of morbidity rates in the study period, the absolute and relative differences were calculated by the morbidity rates adjusted per 100,000 inhabitants over 15 years of the extreme years of the study period. As can be seen, for every person (1.0) over the age of 15 who fell ill with tuberculosis in 2017, 1.1 person fell ill in 2012; reflecting this increase mainly in the municipalities of Guadalupe (TC: 2.3), La Plata (TC: 2.2) and San Agustín (TC: 2.2), which presented twice as many cases for the respective year. However, in 2012 there were 3.2 more people over 15 years of age infected with tuberculosis, compared to 2017, contributing to this difference in rates, the municipalities of Nátaga (DT: -48), Paicol (DT: -40.2), Argentina (DT: -30.9) and Campoalegre (DT: -27.2) that presented more cases for the year 2012.

Table 4: Variability of the adjusted rates of tuberculosis morbidity in the department of Huila during the years 2012 and 2017.

Note: Source: own elaboration.

Table 5: Ratios and differences of adjusted rates of Tuberculosis in the years 2012 and 2017 of the department of Huila.

Note: (CT) Extreme Rate Ratio (2012/2017 Rate); DT: Difference of extreme rates (Rate 2017 – Rate 2012).

Source: own elaboration.

Discussion

The Prevalence of Tuberculosis during 2012 reported 3.2 more cases than in 2017 for each inhabitant over 15 years of age; observing a decrease, reporting a decrease in tuberculosis morbidity of 9.8%, with a positive variability between the years of study (2012- 2017). This result may be related to positive changes in social determinants and to public policy interventions. Due to the characteristic of the descriptive study, we cannot determine if the prevalence of tuberculosis is related to occupation or if there are confounding variables; it is also pertinent to comment that data were obtained from all the inhabitants of the department of Huila from the sources consulted, allowing to incur in information biases, due to incomplete or untrue data in the capture of SIVIGILA, which is why the idea raised by Álvarez and Delgado was taken as a reference in front of the cross-sectional descriptive studies, who indicate that: “Since the exposure and the result are examined at the same time, there is a temporal ambiguity in their relationship, which prevents establishing cause-effect inferences”[7].The prevalence for the years evaluated ranged from 28.8 cases to 32.9 cases per 100,000 inhabitants in people over 15 years of age, indicating that it remains a relevant health problem in our department despite the decrease found. This shows the need to intervene in health related to the purposes of WHO, PAHO and the ten-year public health plan, which seek to eliminate this infectious disease currently classified as one of the main re-emerging diseases. In relation to these facts, it is extremely important to refer: “the global strategy to end Tuberculosis”, which has the “strategic plan: towards the end of Tuberculosis, 2016 – 2025”, a strategy included in the Sustainable Development Goals, which aims to end the epidemics of tuberculosis, malaria and HIV by 2030 [8].

It should be remembered that the mortality rate at the beginning of the twentieth century (1935) was 45.2 per hundred thousand inhabitants [9], allowing to evidence the great impact existing in the last century of Tuberculosis in Colombia, advancing in its control, without reaching the goal of eradication and being classified as a reemerging disease. The results show that 54% of the municipalities present positive changes in the face of the decrease in the prevalence of Tuberculosis in the department, but others a significant negative variation. Public policy must be strengthened throughout the geography of the Department of Huila, but especially in various areas with greater predominance, such as the northern area of Huila, of which approximately 70% of the municipalities with the highest prevalence are. The municipality of Neiva (northern zone), which contributes the highest percentage of cases, this being the capital of the department reports a high prevalence without distinction against sex; unlike the national behavior where the male sex has 64.3%. The areas least affected by Tuberculosis were the central and western areas of the department, which would be valuable to address from the strategic processes of public health management, within the framework of the comprehensive health care policy in these areas. According to Fontalvo, et al. [10], the lack of tuberculosis control in Colombia is due to structural failures related to the health management model that is adopted in the country

In the geographical analysis of the cases against the area of origin (rural or urban) it was reported that in 2013, the highest rate of tuberculosis occurred in the municipality of Altamira, it was the only municipality where there is no difference in cases of tuberculosis between the municipal capital and the rural area; it should be clarified that this result should not divert attention from the trend shown by the current study in greater prevalence in the northern zone, Altamira is a municipality in the central area and is one of the smallest populations of the department, without undervaluing the activities to be carried out in this municipality, there is a marked inequality between the number of inhabitants of rural areas and dispersed areas. It is also observed in 2015 where the municipality with the highest rate of tuberculosis was Agrado. In 2016 the municipality with the highest rate of tuberculosis was Rivera, where 48% of the cases belong to the rural area and 43% belong to the municipal capital; with a high number of visitors, it could be a municipality where it merits a deeper study against the determinants of health and other factors. Finally, it can be concluded that in the department of Huila in the years analyzed the highest concentration of cases occurs in the urban area during the study period, with 79.4% of tuberculosis cases. This behavior found is clearly in line with the behavior of this pathology recorded within history and as reported by the 2017 tuberculosis report of SIVIGILA: where 83.4% of cases occur in urban areas [2]. It is necessary to take into account the existence of prejudices that affect people with the disease [11], which may be more accentuated in rural areas.

The gender assessment of morbidity rates shows similar behavior at the national level based on the report of the epidemiological bulletin 2017 [12], which reports that 64.3% of the cases were male. The municipality of Saladoblanco had no cases of tuberculosis in men (southern area of Huila). On the other hand, the municipality of Neiva presented the worst rates of tuberculosis morbidity in women during the 6 years of study. These results invite us to propose studies on biological and physiological factors related to gender, occupation and interaction with the environment in the department of Huila. Reports of the disease indicate the greater vulnerability of men [13], which may be related to social habits [14], although there is a higher risk for women who are health workers [15]. The Health Insurance Regime shows us a marked inequity in socioeconomic strata in the municipalities of the department, where 63.6% of the diagnosed cases of tuberculosis are affiliated to the subsidized regime, a regime in which the population is classified as vulnerable since they do not have the capacity to pay or do not have formal jobs, which also reflects the reality at the national level (epidemiological bulletin 201712) where 53.4% of the cases correspond to the subsidized regime. The doctors of the 1930s and 1940s agreed that tuberculosis was an economic-social problem of great importance for the progress of the country 9. The situation in Colombia was considered to be extremely serious, that it defended the permanent state protection of tuberculosis, composed of workers and mainly those who earned the least money [16].

In the ethnic differential populations, 0.8% of the cases diagnosed with tuberculosis in the department correspond to indigenous people who are engaged in agriculture, forestry and fishing activities, well below the national reality reported for the year by the epidemiological bulletin 2017 [12] 5.4% of cases occur in the indigenous population. Regarding the relationship of Tuberculosis with work activities in the department of Huila during the study period, of the first 10 occupations that were related to the diagnosis in people are farmers, workers, agricultural, forestry and fishing workers with 9.9%. Farmers represent the most frequent employment in people in the department who are related to the diagnosis of tuberculosis. The above leads to an inference and is that, the department of Huila being a department with eminently agricultural vocation where its main tasks are developed in the field, are carried out by men in greater proportion who reside mainly in the urban area, which in its great majority belong to the subsidized regime, suggesting that agriculture, informality and socioeconomic status related to the health regime could be directly or indirectly related to the high prevalence rate of Tuberculosis. According to the results, formal jobs such as drivers, university professionals, office employees and machinery operators would also be an object population, which should guide any intervention from public policy with a focus on environments. Jobs held by people over 15 years of age in the department, such as unskilled, informal and low-paid labor, would have a risk of acquiring tb disease because of its transmission mechanism for the work they do and for its social determinants.

The literature reports an increased risk of the disease in professions such as veterinarians, slaughterers, miners, prison staff; of public transport and funeral homes and especially health workers [17], due to the accumulated exposure in hospitals, a lack of control plans and inadequate natural ventilation [18,19]. Tuberculosis in Colombia begins to be classified as an occupational disease from Decree 841 of 1946 that regulated article 12 of Law 6 of 1945, by means of which it was legislated for the first time to protect workers in case of occupational diseases, only in certain trades such as hospital and amphitheater personnel, blowtorches, miners, firemen and boilermakers [16]; In 2012, the municipality with the highest rate of tuberculosis was Neiva, where the work performed by infected people were non-university post-secondary technicians and commercial and administrative assistants, followed by vehicle drivers and mobile heavy equipment operators. In a study from Mexico [20], 83.8% of the interviewees are located in the low socioeconomic level, unskilled workers in the informal sector of agriculture and the economy, with incomplete primary education and the other 16.2% of the interviewees are located in the middle socioeconomic level, skilled workers.

Among the main known risk factors for Tuberculosis, hiv infection is the strongest; malnutrition, indoor air pollution, type 2 diabetes mellitus, excessive alcohol consumption and smoking [1]. In the last two years of the study for municipalities with the highest rates of tuberculosis, people who worked as vehicle drivers, mobile heavy equipment operators were more likely to get sick, which may be related to their habits, exposure to toxic agents or their environments. There is consistent epidemiological evidence that independently associates chronic inhalation of biofuel smoke with the development of pulmonary tuberculosis. The pathophysiological mechanisms underlying this association are partially known; biofuel smoke has various effects at the level of the pulmonary parenchyma and the innate immune system which, together, could increase susceptibility to various infections including Mycobacterium tuberculosis [21]. 68.7% of the people who developed tuberculosis during the study period were not classified under any occupation code; this result leads to suggest that most of the occupations in the department of Huila are informal and outside the classification of occupations and as mentioned in previous paragraphs this would determine a great risk for the population and their vulnerability to Tuberculosis; however, it can also be considered problems of underreporting or difficulties in the instruments that collect information on the pathology under study and the occupations of the population in Huila and Colombia. Mining is carried out in some municipalities, being within the top 10 causes in the years studied, therefore, it is important that in this trade all the necessary measures are increased to reduce the prevalence of tuberculosis in this occupation. The relationship of tuberculosis with mining is known, which establishes that silicosis or anthracosiliosis predisposes to pulmonary tuberculosis [22].

Conclusion

The tasks performed by people over 15 years of age related to the diagnosis of tuberculosis are farmers, agricultural, forestry and fishing workers, unskilled, informal and poorly paid labor, in which their risk of acquiring the tuberculosis disease may be in their transmission mechanism or because of the work they perform. In municipalities with high rates of tuberculosis, work is considered at greater risk of developing tuberculosis. such as: technicians, non-university post-secondary, commercial and administrative assistants. It may be indicated that it is necessary to invite health and labor authorities to strengthen the registration and reporting of diseases such as Tuberculosis, especially of diagnosed cases that correspond to workers within a work environment, as well as to strengthen the reporting of occupations which should be adequately coded and monitored, as well as the urgent strengthening of public policies in Huila and in the municipalities where the highest number of tuberculosis cases was found. In the department of Huila, progress has been made in the control of Tuberculosis, however, health policies must be strengthened in the urban area of the department, as well as intervention should be made mainly in the population of the subsidized regime.

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An Open Labeled Multicentric Pilot Trial to Study the Safety and Efficacy of Colloidal Nano Silver Skin Cream in Patients with Various Skin Diseases

Introduction

In addition to increasing incidence rates of lifestyle-related disorders such as obesity and type II diabetes among the young and aging population (especially in developing countries), new challenges to skin healing must be addressed. There is a scarcity of treatments that are both effective and cost-efficient. The use of advanced therapeutic healing methods to promote rapid and complete wound healing in various skin ailments is currently among the top research interests. The financial burden on every nation has led to a desire for novel strategies to achieve expeditious skin healing. In modern society, the desire to retain a youthful appearance has led to the development of minimally invasive dermatological procedures designed to rejuvenate the aging face. Aesthetic treatments, also known as cosmetic treatments, are noninvasive procedures designed to counteract the effects of aging and restore the youthful appearance of the skin. To counteract the effects of aging on the face and recreate a youthful appearance, numerous aesthetic skin procedures have been developed. Aesthetic skin procedure can be performed on almost any part of the body, though it is mostly done on the face and neck. The commonest forms of such non-invasive procedures include TCA peel (trichloroacetic acid chemical reconstitution of skin scars), yellow peel, salicylic acid peel, glycolic peel, black peel (with or without comedone extraction), laser hair removal for hirsutism, microneedling radiofrequency (MnRF) for post-acne scarring, etc. After a procedure, the primary aim of the skincare regimen is to restore, soothe and rejuvenate the skin. This includes reducing erythema and irritation, protecting the skin from secondary infections, and keeping the skin hydrated.

Common cosmetic procedures that leave the skin intact but inflamed include microdermabrasion; nonablative laser resurfacing procedures; mild chemical peels and fillers or Botox. The procedures that leave the skin with open wounds or broken skin barriers include deep chemical peels; ablative laser resurfacing treatments and surgical procedures, such as eyelifts, rhinoplasty, and facelifts. These procedures bring about certain unwanted side effects such as redness, burning sensation, itching, dryness, etc. Such side effects persist for some time before any desired effects of the procedure done could be seen. At this point, topical agents are indispensable to take care of post-procedural skin damage. Fungal infection likewise called, mycosis, is a fungus-caused disease. Fungal infections are generally classified as superficial, subcutaneous, or systemic, depending on which body part is afflicted [1,2]. Fungal infections are widespread and prevalent, impacting over one billion individuals each year[3]. Annually, an estimated 1.7 million people die from fungal diseases [4]. Some superficial fungal infections comprise common tinea of the skin, such as tinea of the body, groin, hands, feet, and beard. The common yeast infections are pityriasis versicolor and candidal intertrigo [5]. Eumycetoma and chromoblastomycosis are two subcutaneous kinds that affect tissues in and underneath the skin[5,6]. Cryptococcosis, histoplasmosis, pneumocystis pneumonia, aspergillosis, and mucormycosis are examples of severe systemic fungal infections. Signs and symptoms, microscopy, culture, and sometimes a biopsy and medical imaging are used to make a diagnosis. Antifungal drugs, usually in the form of a cream, or by mouth or injection, are used to treat the infection, depending on the type and severity of the infection. Miconazole, terbinafine, luliconazole, eberconazole, ciclopirox olamine, oxiconazole creams are used to treat fungal infection[7]. Itraconazole and voriconazole, two newer antifungal agents are now available. These agents have a broad spectrum of action that includes dermatophytes, Candida species, and nondermatophyte molds.

Material and Methods

Study Design

This study was an open-labeled study to evaluate the efficacy of a colloidal Nano Silver cream in patients who have undergone non-invasive cosmetic procedures and suffering from certain fungal infections like tinea, intertrigo, and pemphigus/ bullous pemphigoid. The study was conducted at three centers viz. Sparsh Derma Centre, Dr. Pathak’s Skin World Clinic, and Upasani Hospital, Mumbai, India, after obtaining the approval from Inter System BioMedica Ethics Committee, Mumbai, and registration with the Clinical Trial Registry of India (CTRI/2021/01/030388).

Study Procedure

A total of 24 patients, including 9 males (Age ranging from 22 to 60 years) and 15 females (Age ranging from 26 to 58 years), who met the inclusion criteria were selected for the study after proper history taking, clinical examination, and investigations as per the criteria of choice mentioned in the protocol. (Table 1) Colloidal Nano Silver Skin Cream was manufactured and supplied by Viridis BioPharma Pvt Ltd, Mumbai.

Table 1: Various dermatological conditions and the number of patients in each condition.

Post-Aesthetic Skin Procedures

A. Chemical Peeling: A chemical peel is a technique used to improve the appearance of the skin on the face, neck, or body. In this process, a chemical solution is applied to the skin, causing it to exfoliate and eventually peel off. As the skin regenerates, it usually becomes smoother and less wrinkled. This study included patients (n = 4) suffering from the adverse effects of commonly used chemical peel procedures such as TCA CROSS, yellow peel, black peel (with comedone extraction), and glycolic peel (30%). The side effects included redness, burning sensation, scabbing, and swelling in the treated area. Additionally, the patients also suffered excruciating pain, skin scarring, and infections post-procedure. The patients were treated with Colloidal Nano Silver Skin Cream. As a remedy for the post-procedure side effects, Colloidal Nano Silver Skin Cream was applied to the affected skin area for 7 days, i.e., twice a day.

B. Laser Hair Removal: Laser hair removal is a light-based technology to remove unwanted hair. In this process, a lightabsorbing pigment in the follicles absorbs light and impairs hair growth. Some patients had received laser treatment for hair removal. Post-procedure, they experienced red spots and dark spots on the chin, upper lip, and cheeks. The side effects included a burning sensation and irritation in the affected area. In such situations, other potential side effects include swelling, redness, and skin scarring. Blisters are rare but are more likely in people with darker complexions. However, permanent scarring or changes in skin color is rare. In order to relieve the patients (n = 2) of the post-procedure side effects, Colloidal Nano Silver Skin Cream was applied to the affected skin, over a period of 7 days, twice a day. No other moisturizer or any anti-inflammatory cream was prescribed. The patients attended follow-up every two days. However, as per a standard protocol, an ice pack, sunscreen, moisturizer, or cold water was applied only after the completion of the 7-day period to ease any discomfort.

C. Microneedling Radiofrequency (MnRF): Atrophic acne scars are dermal depressions commonly caused by the degradation of collagen and inflammation. There are many treatments available to improve acne scarring. The most common therapies include chemical peeling, subcision, dermabrasion, fillers, and punching. However, many a time they have disappointing results in terms of certain side effects. Comparatively, MnRF is a simple, safe, effective, and minimally invasive therapeutic technique. Needles are introduced into the skin with a preselected depth. RF is delivered through these needles to heat the dermis. The benefits of RF are that it is color blind and can be used on all skin types. However, there are certain common side effects which include erythema, crusting, pain, infections, post-inflammatory hyperpigmentation, scarring, needle track marks, a flare-up of acne, and milialike eruptions. A post-procedure application of sunscreen and moisturizer is necessary to ensure that the skin is adequately cooled. MnRF treatment was performed on two subjects (n = 2) suffering from post-acne scarring all over their faces. Post-procedure, the skin appeared red, swollen, and tender. Erythema (all over the face) and a severe burning sensation in the affected area were also observed. During the next 7 days period, Colloidal Nano Silver Skin Cream was applied (twice a day) to the affected skin to alleviate the unwanted effects of the MnRF procedure.

Tinea Infections

Patients with various types of tinea infections (n = 12) were also enrolled in this study (Table 2). Depending on the source of the etiologic agent, the clinical presentation varied and included scaly erythematous plaques, severe itching, and burning sensation in the affected areas. Patients in some cases had scratched extremely hard, resulting in pustular lesions and exudation, which further led to a bacterial infection. In cases of Tinea cruris (n = 4) and Tinea corporis (n = 7), both sides of the body were equally affected. Therefore, one affected side was treated with a topical antifungal agent only, while the other side was treated with a topical antifungal cream plus Colloidal Nano Silver Skin Cream. The rate of improvement on both sides was assessed. In the case of Tinea incognito, the topical antifungal cream plus Colloidal Nano Silver Skin Cream was applied on the back of the trunk, and a topical antifungal cream only was applied on the underarm.

Table 2: Clinically relevant tinea and the site of infection.

Intertrigo

Two cases of intertrigo were reported. The first case had genital vitiligo with small erosion and thinning of vulval skin. The patient later developed intertrigo in both inguinal regions with more erosion on the right side compared to the left side. Erosion and cracks with an erythematous border were present on the right side. The left side had minimal erythema with no erosion. The other case presented with an erythematous scaly patch on both sides of the groin. Itching and burning sensations in the infected site were evident in both cases. Both sides showed similar signs of infection. A topical antifungal cream only was applied on the right side, and on the left side, the topical antifungal cream plus Colloidal Nano Silver Skin Cream was applied. For the topical antifungal cream plus Colloidal Nano Silver Skin Cream treatment, the topical antifungal cream was applied in the morning while Colloidal Nano Silver Skin Cream was applied in the evening on the left side. On the right side, for the topical antifungal cream-only treatment, the same was applied at both times, i.e., in the morning and evening. All the patients received oral antifungals throughout their treatment period.

Vulvitis

One patient presented with a scaly well defined erythematous lesion on the left vulval region. The patient had previously applied steroids locally and was on oral fluconazole but there was no improvement. The patient complained of a severe burning sensation and itching in the affected areas. Upon inclusion in this study, the patient received oral antifungal medication and Colloidal Nano Silver Skin Cream (once a day) along with Candid Gel (once a day) for local application. Additionally, a soap containing Ketoconazole (2% w/v) and Triclosan (0.3% w/v) was prescribed for washing the affected area.

Bullous Pemphigoid

A 50-year-old female presented with vesiculobullous disorder. She had a few bullae on the back and breast folds. The patient had been on steroids and cyclosporine. She had intense pruritus and erosions on the back. She was prescribed azathioprine and steroids orally and Colloidal Nano Silver Skin Cream twice a day was given for topical application.

Results

Post-Aesthetic Skin Procedures

A. Chemical Peeling: Patients with acne scars, including deep ice pick acne scars, needed to have their damaged skin repaired. They experienced several side effects after the chemical peel procedure. The side effects included redness, burning sensation, itching, scabbing, and swelling in the treated area. Additionally, some patients also suffered excruciating pain, and infections post-procedure. Colloidal Nano Silver Skin Cream was applied to the affected area over a period of 7 days. A reduction in redness, red marks, and dark scars was observed within 7 days of the application. The patients showed improvements with no burning sensation or itching. Scabbing and swelling disappeared. The skin appeared healthier with a considerable reduction in acne scar marks.

B. Laser Hair Removal: As a result of laser treatment, patients reported redness, dark spots, and a burning sensation in the treated area. The patients experienced tenderness around the lips. After 7 days of application of Colloidal Nano Silver Skin Cream, the affected site did not show redness, swelling, or dark spots. The burning sensation subsided, and the skin felt normal.

C. Microneedling Radiofrequency (MnRF): Patients with post-acne scarring all over their faces received MnRF treatment. Post-procedure, the skin appeared swollen and tender. The other side effects included erythema (all over the face) along with a severe burning sensation. Within 7 days of application of Colloidal Nano Silver Skin Cream, the skin appeared normal with no redness. Patients reported a considerable reduction in burning sensation and erythema.

Tinea Infections

In cases of tinea infections, itching, burning sensation, and bacterial infection reduced significantly (within 2 weeks) in the affected areas to which the topical antifungal cream plus Colloidal Nano Silver Skin Cream was applied, in comparison to the areas where topical antifungal cream-only was applied. However, the dryness, pigmentation, and erythema subsided on both sites. The pustules in the topical antifungal cream plus Colloidal Nano Silver Skin Cream treated areas were much drier in comparison to the sites treated with topical antifungal cream only.

Intertrigo

In the left inguinal region, intertrigo was treated with the topical antifungal cream plus Colloidal Nano Silver Skin Cream. The healing was faster in the left inguinal region when compared to the right inguinal region where the topical antifungal cream only was applied. Within 2 weeks of the application of the topical antifungal cream plus Colloidal Nano Silver Skin Cream, the erosion, and cracks healed significantly in the left inguinal region. There were no signs of rawness or burning sensation. The erythematous border was not visible. However, this was not true for the right inguinal region.

Vulvitis

Within 7 days of the application of the Colloidal Nano Silver Skin Cream, the symptoms of itching and burning sensation eased. The scaly erythematous lesion was reduced. The patient continued the application of the Colloidal Nano Silver Skin Cream for 3 more weeks. By the end of the 4th week, the scaly erythematous lesions subsided significantly though minor traces were still present with no defined borders. The Colloidal Nano Silver Skin Cream was well accepted and tolerated by the patient.

Bullous Pemphigoid

Within a span of 7 to 15 days, the burning sensation subsided completely, and the erosions healed effectively. Colloidal Nano Silver Skin Cream Skin had a cooling effect, improved the healing, and was found to be non-messy. In addition to not being sticky or oily, it did not cause discomfort to the patient. The patient willingly continued the application of Colloidal Nano Silver Skin Cream till all the lesions healed.

Discussion

In addition to providing protection against dehydration and external pathogens, the skin serves as a barrier between the body’s internal organs and the outside environment [12]. Since the skin is constantly exposed to the outer atmosphere, it is very susceptible to various lesions, such as infections, burns, ulcers, and wounds. In the aftermath of an injury, the human body triggers a complex cascade of biological reactions to repair and regenerate damaged or lost tissue. Several mediators, including extracellular matrix (ECM) molecules, platelets, inflammatory cells, growth factors, cytokines, and chemokines, interact in a synchronized and integrated manner during various phases of hemostasis, inflammation, migration, proliferation, and tissue remodeling[13]. There are several wound care treatments and therapies available to speed up healing, prevent scarring, and improve the quality of regenerated skin [13]. Increasingly, cosmetic surgery and cosmetic procedures (laser, dermabrasion, fillers, microinjections, peelings, and micro-needling) are also a potential source of skin damage. Unlike most surgical procedures or traumatic damage that result in wounds, some cosmetic procedures involve causing an injury to the skin to stimulate the body’s natural healing process and achieve the desired effect. In order to achieve optimal results from any type of exfoliation treatment, the skin must be protected. Facilitating a reduction in inflammation and guarding against any sort of secondary infection are all necessary for lasting skin rejuvenation. Basic skincare seems to have a key role during the remodelling phase of wound repair and skin regeneration. In this background, it is important to note that Colloidal Nano Silver Skin Cream provides a barrier and maintains a moist microenvironment required for optimal healing.

Colloidal Nano Silver Skin cream was studied in post aesthetic skin procedures and was found to be very effective in relieving symptoms such as erythema, burning sensation, swelling, pain and itching. A female patient with acne scars who underwent glycolic acid peel 50% applied Colloidal Nano Silver skin cream twice daily for 1 week post procedure (Figure1(a)). It was interesting to note that her symptoms resolved rapidly, scars reduced significantly and her skin was brighter after treatment with Colloidal Nano Silver skin cream (Figure1(b)). Tinea is the most common type of fungal infection. Depending on the affected site, these have been classified clinically as tinea corporis (body), tinea cruris (groin), tinea capitis (head), tinea incognito (steroid modified), tinea faciei (face), tinea barbae (beard), tinea manus (hand), tinea pedis (foot), and tinea unguium (nail), etc. Tinea corporis is a superficial fungal infection and it may occur on any part of the body. The common organisms which cause fungal infections are Trichophyton mentagrophytes and Micosporum canis. Tinea cruris, also known as ‘jock itch’, is a dermatophyte fungal infection of the groin region, more often seen in males. It is more specifically located between intertriginous folds of adjacent skin, which can be present in the groin or scrotum, and be indistinguishable from fungal infections caused by other species of tinea. Tinea incognito is a fungal infection of the skin caused by the presence of a topical immunosuppressive agent. As a result of commonly used agents such as topical corticosteroids (topical steroids), the fungal infection in the skin often loses its characteristic features. Due to suppression of inflammation, it may have a poorly defined border, skin atrophy, telangiectasia, and florid growth. Tinea can often be diagnosed based on appearance, but a potassium hydroxide preparation or culture should be performed in cases of atypical appearance. Acceptable treatments for tinea include terbinafine and fluconazole. Oral antifungal agents may be prescribed in severe cases, failed topical treatment, and when the patients are immunocompromised. In cases of Tinea incognito, topical corticosteroids are discontinued. Attention should be given to the resolution of the lesions.

Figure 1.

In the current study, the affected sites treated with a topical antifungal cream plus Colloidal Nano Silver Skin Cream showed better improvement in terms of skin appearance, symptoms of itching, burning sensation, and management of bacterial infection (in some cases) due to excessive scratching of the affected areas in comparison to the affected sites that were treated with topical antifungal cream only. It is of great interest to review the case of a 28- year male patient diagnosed with Tinea incognito, in the underarm and on the back of the trunk (Figure 2 (a)). Erythema with dark circled pigmentation in both the sites of infection was evident. In the underarms, a topical antifungal cream only was applied, whereas, in the back of the trunk, topical antifungal cream plus Colloidal Nano Silver Skin Cream was applied for 2 weeks. Within 2 weeks of the application of topical antifungal cream plus Colloidal Nano Silver Skin Cream, the symptoms such as itching, pigmentation, burning sensation, and bacterial infection reduced significantly in the patch on the trunk. The reduction in bacterial infection was indicated by the dryness of pustules in the affected patch on the trunk. However, no such change was observed in the infected site at the underarms which was treated with topical antifungal cream only (Figure 2(b)). Intertrigo is inflammation of skinfolds caused by skin-onskin friction. It is a common skin condition affecting opposing cutaneous or muco-cutaneous surfaces. The condition appears in natural and obesity-created body folds. The friction in these folds can lead to a variety of complications such as secondary bacterial or fungal infections. The usual approach to managing intertrigo is to minimize moisture and friction with absorptive powders or with barrier creams. Secondary bacterial and fungal infections are treated with antiseptics, antibiotics, or antifungals. In the current study, the intertrigo in the left inguinal region was treated with Colloidal Nano Silver Skin Cream in addition to the topical antifungal cream. The left inguinal region healed faster in comparison to the right inguinal region. The left side showed signs of reduction in erosion and cracks in the skin along with improvement in lesions (Figures 3(a) & 3(b)).

Figure 2.

Figure 3.

The symptoms of rawness and burning sensations in the left side subsided much earlier when compared to the right side. Vulvitis is an inflammation of the vulva. The causal factor could be an infection, a change in hormones, or antibiotic use. Vaginal infections resulting in vulvitis are commonly caused by yeast, bacterial vaginosis, and trichomoniasis. Symptoms of vulvitis include itching, irritation, burning sensation, redness, swelling, dryness, rashes, and blisters or bumps in the infected sites. Yeast infections are treated with antifungal medications. For both bacterial vaginosis and trichomoniasis, metronidazole clindamycin topical applications are used.In the current study, a 25-year-old female presented with a scaly well defined erythematous lesion on the left vulval region (Figures 4(a) & 4(b)). She was diagnosed with Vulvitis. As it turned out, the patient insisted on only applying Colloidal Nano Silver Skin Cream and not Candid Gel as part of the treatment. This is due to the fact that the application of Colloidal Nano Silver Skin Cream had a cooling and soothing effect, whereas the latter left a mild burning sensation. Colloidal Nano Silver Skin Cream was well accepted and tolerated by the patient. This effect can be attributed to its use as a moisturizer as well. A similar cooling effect was observed by another patient who was suffering from the vesiculobullous disorder. The patient had a few bullae on the back and breast fold (Figures 5(a) &5(b)).

Figure 4.

Figure 5.

SilverSol® from American Biotech Labs (ABL), USA is recognized as one of the newest and most innovative solutions for advanced skin healing and rejuvenation. The gel can be used to help soften, soothe, and rejuvenate the skin. It can also be used in combination with lotions or moisturizers. It is non-irritating, non greasy, and contains no alcohol. It can be applied all over the body, even underneath make-up and moisturizers, to help heal the skin naturally all day long. SilverSol® contains silver nanoparticles of size 5-15 nm with metallic silver in the interior and silver oxide in the exterior, i.e., multivalent silver (I, III) oxide, Ag4O4. Silversol® combines the properties of ionic silver and Ag4O4 to provide optimum results. Its multi-mode action ensures that microbes are relentlessly bombarded and annihilated. Various studies have been conducted using Nano Silver. It has proven to be effective against bacteria, yeast, fungus, black mold, virus, and parasites. It is well known that a silver cream is effective in providing immediate relief and sustained antimicrobial action against a broad spectrum of wound pathogens without inducing bacterial resistance. Various in vitro studies have reported antimicrobial activity of SilverSol® against Methicillin-resistant Staphylococcus aureus (MRSA) [14]; Klebsiella pneumoniae, S. typhi, S. flexneri, Vancomycinresistant E. faecalis (VRE), drug-resistant E. coli, drug-resistant P. aeruginosa, Fungi - C. albicans [15]; Gram-negative bacteria. Reportedly, SilverSol® has a wide range of antimicrobial activity when compared to the antibiotics such as penicillin, macrolides, cephalosporins, fluorinates quinolones, and tetracyclines [16]. In a recently conducted in vitro study by Tran et al, a colloidal silver gel (Ag-gel) was found to be effective in inhibiting bacterial biofilm formation by the principal bacteria (S. mutans, S. sanguis, and S. salivarius) that cause plaque formation and tooth decay [17].

In this study, the Killing curve tests were performed as per CLSI (Clinical and Laboratory Standard Institute). The tests were carried out to determine the killing rate of SilverSol® and ionic silver. SilverSol® showed a superior killing rate against MRSA and S. aureus when compared to Ionic Silver [Data on file]. SilverSol® is a breakthrough among the currently available advanced woundhealing technologies as it offers a next generation therapy for the treatment and management of severe, chronic, and infectious wounds that are difficult to manage. The clinical efficacy of SilverSol® has been proven in wounds of varied etiology, such as acute and traumatic wounds, lacerations, diabetic-, pressure-, and venous- ulcers, infectious wounds, third-degree burns, MRSA, and Vancomycin-Resistant Enterococcus (VRE) infected wounds [18]. Colloidal silver gel wound dressing has shown complete inhibition of S. aureus, P. aeruginosa, and Acinetobacter baumannii in vivo and in vitro [19]. An in vitro study compared the efficacy of a combination of 5% Betadine solutions and silver colloidal gel with each individual treatment in inhibiting the growth of both Gramnegative and Gram-positive bacteria in wound infections. The study demonstrated that the combination of 5% Betadine solution and Ag-gel completely inhibits the growth of bacterial biofilms including those of K. penumoniae. However, the individual treatments were not found to be effective in killing all the bacteria tested [20].

Skin Irritation Test conducted according to ISO 10993-10 showed no signs of irritation. Maximization Test for Delayed Hypersensitivity was conducted according to the ISO 10993- 10. SilverSol® did not show any signs of hypersensitivity. Intracutaneous (Intradermal) Reactivity Test was conducted according to the ISO 10993-10. The primary irritation responses to SilverSol® were negligible [Data on file]. SilverSol® gel has been rigorously tested in animals, humans, and laboratory agents with a delivery system consisting of ingested, injected, and cytotoxic experiments. A number of studies have shown that SilverSol® is absorbed, distributed, excreted, and passed through the body unchanged. SilverSol® nanoparticles produce no metabolites. The unique structure of SilverSol® prevents silver from falling out of the solution, which can otherwise accumulate in tissues causing argyria (a condition observed with ionic/colloidal silver). It is nontoxic to humans [21]. SilverSol® is thus a highly effective and safe antimicrobial product that leverages the latest nanotechnology. The other ingredients in Colloidal Nano Silver Skin Cream include coconut oil (natural skin protection & moisturizer), vitamin E (powerful antioxidant), and hyaluronic acid (natural skin moisturizer). Coconut oil contains saturated fats that protect the skin from moisture loss and provide excellent emollient properties, while the fatty acids present have strong antimicrobial properties. Because vitamin E is a powerful antioxidant, it prevents skin damage from free radicals and reactive oxygen species and reduces UV-induced skin inflammation. Hyaluronic acid hydrates the skin and reduces the appearance of fine lines and wrinkles. Hyaluronic acid also helps relieve inflammation and regulate tissue repair in damaged skin.

Conclusion

Colloidal Nano Silver Skin Cream, which contains SilverSol®, in combination with other skin-protective ingredients, offers a new and innovative solution for skin rejuvenation in post-cosmetic skin procedures and ensures significantly better treatment of various fungal skin infections when used as an adjuvant to oral and/or topical antifungal agents. It was observed to have many benefits with no side effects. The results of this study demonstrate the efficacy of Colloidal Nano Silver Skin Cream in skin rejuvenation and fighting infections. Further studies with specific indications on a larger sample size followed by multicentric placebo‑controlled trials can clearly establish the efficacy of SilverSol®.

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