Correlation between the appearance of fungal infection on skin and the fungal species causing it among children.

Not yet recruiting

• Conditions: Other specified local infections of the skin and subcutaneous tissue,

• Registration Number: CTRI/2020/12/029992
• Lead Sponsor: Father Muller Medical College

Brief Summary

**6.1 INTRODUCTION AND NEED FOR THE STUDY**

Superficial fungal infection is seen in about 20-25% of the global population. Hence it’s a very common infective disease. The most common causative agents for cutaneous mycosis are anthropophilic and zoophilic dermatophytes.1

Dermatophytes are keratinophilic fungi, that produce enzyme keratinase, to invade stratum corneum of the skin and other keratinized tissues.2

Microsporum, Trichophyton, Epidermophyton are the three genera causing dermatophytosis.3

Prevalence of dermatophytosis is 13-27.6% in India.4,5

Although the disease is not life threatening, it can cause discomfort and distress. Treatment is usually started without any laboratory investigations and without identifying the underlying causative factors .6

Tinea capitis is more prevalent than tinea corporis among children in a study conducted in Ethiopia by Seebacher *et al*. 7

However in India, even though dermatophytosis is less compared to adults , there’s an increase frequency of tinea in children including infants. The treatment of dermatophytosis in children is usually limited to topical antifungals. This might be due to rapid turnover of skin leading to better clinical response to topicals as compared to adults. 8

Various factors like standard of living, hygiene, local customs will influence the disease spectrum. 9

Also, age, sex, ethnicity, environmental temperature and humidity influence the prevalence of the disease in a particular area. 10

Dermatophytosis has become a menace due to various factors like host, agent, environment and also pharmacological agents. Due to the presence of large number of freely available multi combination drugs with steroid, dermatophytosis has not only become a common recurrent disease but also a chronic and recalcitrant one. In a recent article, Verma has compared ‘tinea incognito’ and ‘steroid  modified tinea ’and concluded that topical steroids do modify the morphology of tinea to varying extent but do not necessarily make the disease difficult to recognize, therefore the majority of them are better described as steriod modified tinea rather than tinea incognito. 11

**REVIEW OF LITERATURE**

A study done by Noronha TM et al in 2007-08 showed that the most common species found among dermatophytosis infection in North Karnataka was T.mentagrophytes (48.3%)  followed by T. rubrum, which is contrary to most of the Indian studies.12

 Another Study by Gupta SK et al in 2014 showed dermatophytosis infection was more commonly seen among the middle age group and it was less common in the extremes of age. Incidence was found to be higher in males than females. In case of socio-economic status, it was predominantly seen in lower middle class. Hot and humid climate and poor hygiene also played a vital role in fungal growth.2

Study done by Maulingkar et al found that cutaneous dermatophytosis was  noted in 3.1% of children in 0–10 years of age group. Out of which tinea cruris cases were more common.6

 Study conducted in Madras by Ranganathan S et al stated that T rubrum was more common, followed by T mentagrophytes. Similar to many studies dermatophytosis was commonly seen in very low, low and middle-income group. Chronicity of the disease was also found to be in the lower income specter.13

 A study done by Savitha  Chaudhary et al9 in 2011 showed that out of 980 patients with Tinea 550patients are using Topical steroids.Male preponderance was noted and disseminated form was the most common variety.14

     **OBJECTIVES OF THE STUDY:**

 1.    To assess the clinical pattern and mycological isolates from the lesions of dermatophytosis in paediatric age group.

2.    To assess the association of fixed dose combinations containing steroids and antifungals with clinical and mycological pattern of cutaneous dermatophytosis in paediatric age group.

  **MATERIALS AND METHODS:**

 **Source of data and sample size**

A minimum of 44 patients satisfying inclusion and exclusion criteria, attending the out-patient department of  Dermatology at Father Muller Medical College Hospital, Mangalore.

 **Selection Criteria**:

1.    Inclusion Criteria

·   Patients age group of 1-14 years with clinical diagnosis of cutaneous dermatophytosis in glabrous skin (Tinea faciei, Tinea corporis and Tinea Cruris).

·   Both boys and girls will be included in the study.

·   Patients /parents/guardians who are consenting to participate in the study.

 2.    Exclusion Criteria

·       Patients with other pre-existing skin disorders.

·       Patients/parents/guardians who are not willing to participate in the study.

**Method of collection of data**

Data will be collected from January 2020 to August 2020 with a minimum sample size of 44. Written and informed consent will be taken from the parents or guardians of participants. Patients treated with over the counter drugs including antifungals or topical corticosteroids will also be included in the study.

 **Methodology**

A minimum of 44 patients clinically diagnosed with cutaneous dermatophytosis will be taken up for study. A detailed history and clinical examination will be done.

Age group of 1 – 14 years and both sexes will be included in this study.

Skin scales will be collected from patients with Tinea Corporis, Tinea Cruris and Tinea faciei on a clean glass slide. Specimen collected will be subjected to 10% potassium-hydroxide (KOH) wet preparation, fungal elements will be identified by branching fungal hyphae, under low power magnification (10x) and low illumination.

After direct microscopic examination, irrespective of demonstration of fungal elements, skin scales will be collected in a sterile plastic container and the specimen will be inoculated into a test tube with Sabouraud’s dextrose agar with 0.05% chloramphenicol and 0.5% cycloheximide. This will be incubated at 25°C and 37°C for up to 4 weeks. If no growth is found even after 4 weeks, it will be considered negative for growth of fungi. Fungal isolates will be identified on the basis of morphology of the colony, growth rate, microscopy, and pigmentation with Lactophenol Cotton Blue mount.

**Sample Size Calculation**

Assuming prevalence (p) of cutaneous dermatophytosis is 13%.4

Sample size (n)=   Za2 p (1-p)   = 44

e 2

where Za=1.96 or 95% Confidence Interval

p = 0.13

e = allowable error = 10%

 **Type of study:**

Cross sectional observational study

   **STATISTICAL ANALYSIS:**

Collected data will be analyzed by Frequency, and Chi-Square test.

 **IMPLICATIONS OF THE STUDY:**

·       To identify the current common species causing dermatophytosis in paediatric age group.

·       To bring awareness among the people regarding the risks of using over the counter drugs that contains multiple combinations of drugs including steroids and that could further cause resistance in treating.

·       To identify the changing morphological pattern of disease due to fixed drug combination drugs containing corticosteroids.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-12-22
• Study Start: 2020-12-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients age group of 1-14 years with clinical diagnosis of cutaneous dermatophytosis in glabrous skin (Tinea faciei, Tinea corporis and Tinea Cruris).
• Both boys and girls will be included in the study.
• Patients /parents/guardians who are consenting to participate in the study.

Exclusion Criteria

• Patients with other pre-existing skin disorders.
• Patients/parents/guardians who are not willing to participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nil, no intervention done	nil

Trial Locations

Locations (1)

Father Muller Medical college; 🇮🇳 Kannada, KARNATAKA, India

Father Muller Medical college

🇮🇳Kannada, KARNATAKA, India

Dr Durga Satheesh

Principal investigator

9605866488

durgasatheesh@gmail.com