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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Cases are patients with superficial dermatophytosis and controls are healthy volunteers, |
|
Intervention / Comparator Agent
|
|
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 resistanceâ€
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 |