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CTRI Number  CTRI/2017/07/009032 [Registered on: 12/07/2017] Trial Registered Retrospectively
Last Modified On: 11/07/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   A multicentre study to evaluate superficial fungal infections 
Scientific Title of Study   A multicentric study to evaluate the hst and pathogen factors in recurrent dermatophytoses 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Dogra 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research,Chandigarh 
Address  F Block,Faculty offices, 2nd level, Nehru hospital,Department of dermatology, Post Graduate Institute of Medical Educations and Research, Chandigarh-160012

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  sundogra@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunil Dogra 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research,Chandigarh 
Address  F Block, 2nd level, Nehru hospital,Deaprtment of dermatology, Post Graduate Institute of Medical Education and Research, Chandigarh-160012

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  sundogra@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunil Dogra 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research,Chandigarh 
Address  F Block,Faculty offices, 2nd level, Nehru hospital,Department of dermatology, Post Graduate Institute of Medical Education and Research, Chandigarh-160012

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  sundogra@hotmail.com  
 
Source of Monetary or Material Support  
Indian Association of Dermatologists, Venereologists and Leprologists IADVL National Headquarters, 4772-73 Pvt No.,T-3 & T-4, 3rd Floor, 23 Bharat Ram Road, Darya Ganj, New Delhi-110002 
 
Primary Sponsor  
Name  Indian Association of Dermatologists Venereologists and Leprologists 
Address  IADVL National Headquarters, 4772-73 Pvt No.,T-3 & T-4, 3rd Floor, 23 Bharat Ram Road, Darya Ganj, New Delhi-110002 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NONE  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suni Dogra  PGIMER  Department of dermatology,PGIMER,Sector 12, Chandigarh -160012
Chandigarh
CHANDIGARH 
9855005941

sundogra@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cases are patients with superficial dermatophytosis and controls are healthy volunteers,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Study population
1.All patients above the age of 12 years diagnosed clinically to have recurrent dermatophytoses (excluding nail and scalp infections).

Control Group:

1.First episode or Only single episode of tinea corporis/cruris/facei in last 12 months

The inclusion criteria for centres:

1.There should be an NABL-accredited mycology laboratory equipped for standardized dermatophyte cuture available (the proof of such accreditation must be attached with the application).

2. The lab director or the mycologist in-charge must give signed consent in a pre-approved format: 1) agreeing to be a co-investigator for the project, and 2) agreeing to give unimpeded access to the lab for the said purpose (dermatophyte culture) during the full tenure of the project.

3. The Investigator must take full responsibility of and provide proof thereof facilities of transportation of biological samples from the site to PGIMER.
 
 
ExclusionCriteria 
Details  1.Immunocompromised.
2.Pregnancy
3.Lactation 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. To estimate the prevalence and clinical patterns of recurrent dermatophytoses
(excluding nail and scalp infections).
 
1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the host and environmental risk factors associated with recurrent dermatophytoses.
2. To study the antifungal susceptibility patterns in these patients.
3. To study relationship between the potency and quantity of corticosteroid use with severity and chronicity of dermatophytosis

 
1 year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 

Superficial mycoses are the commonest fungal infections of humans, and mostly caused by keratinophilic fungi called as dermatophytes. Dermatophytes use keratin as a nutrient during skin, hair and nail infections. Based on the formation and morphology of their conidia, which are the structures of their asexual reproduction, they are classified into three genera, Trichophyton, Microsporum and Epidermophyton. So far, about 30 species of dermatophytes have been identified as human pathogens.

 

Dermatophytes infect host surfaces containing keratin, including skin, hair, and nails. Both climate and lifestyle contribute to the prevalence of dermatophyte infections. Tropical climates and overcrowding predispose population to dermatophyte infections. Increased urbanization, including the use of occlusive footwear, tight fashioned clothes, community showers and participation in sports, has also been linked to higher prevalence.

Dermatophytes are transmitted by direct contact with infected animals and humans or by indirect contact with contaminated fomites. Typical skin lesions of dermatophytes are annular, erythematous and pruritic patches/plaques which may be mild or severe depending upon the immunologic status of the host. Dermatophytoses occur as a result of direct invasion of the fungus or hypersensitivity reactions to the microorganism and/ or its metabolic products. It is a common cutaneous morbidity as a result of severe itching and social impairment.

 

  Over past few years, antifungal resistance has emerged due to irrational use of antifungal agents in cutaneous mycoses. Rampant use of corticosteroids containing topical polycombinations peculiar to India may be contributing to this fast growing menance of chronic/recurrent dermatophytosis and “antifungal drug resistance” in tis country particularly. The condition can be treated by local or systemic antifungal therapy depending on the site and severity of the lesions. Some studies around the world are also noticing resistance to common antifungal drugs used for the treatment of such dermatophytic infections. The incidences of relapse and recalcitrant cases are increasing in spite of therapy with complete course of antifungal agents resulting in large pool of recurrent dermatophytoses in the community.

Recurrent dermatophytoses refers to persistent dermatophytoses that run a chronic course with episodes of remission and exacerbation. These patients are potential source of infection not only to their family members but also to the public, thus posing a financial and public health problem. There are various proposed causes which might contribute to chronicity/recurrence. These include antifungal drug resistance, poor hygiene, intra-familial fungal infections and host factors such as immuno-compromised status, diabetes mellitus, atopy and intake of systemic steroids. The problem of recurrence of superficial dermatophytes causes significant distress to the patients socially, emotionally and financially.

      

Study form north India showed non-responders to gold standard drug griseofulvin among the tinea     capitis patients. In 2002, Mukherjee PK et al found  Trichophyton rubrum strain exhibiting primary resistance to terbinafine. In study conducted by Sarifakioglu E et al (2007) on 100 isolates of onychomycosis, they found terbinafine has lowest  minimum inhibitory concenteration (MIC) followed by itraconazole and fluconazole showed greatest variation in MIC.  In a study conducted by Klafke GB et al (2014) on 100 isolates of onychomycosis they found high MIC value for Fluconazole and Itraconazole in 66.7%  and 25% of isolates of T.rubrum respectively.7 In one of the study, it was found that recurrent dermatophytoses was more frequent in low socioeconomic group and tinea corporis and tinea cruris were found to be the most clinical forms associated with chronicity.

 

In this study, we will analyse the prevalence, clinical patterns, pathogens and profile of antifungal susceptibility in patients suffering from recurrent dermatophytoses 
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