| CTRI Number |
CTRI/2023/06/053876 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical presentations of steroid modified fungal infection and identification of causative fungus using MALDI TOF ( Matrix assisted laser desorption/Ionisation – Time of flight ) technology |
|
Scientific Title of Study
|
Clinical spectrum and mycological delineation of Tinea incognito using matrix assisted laser desorption / ionisation - Time of flight (MALDI-TOF)Technology |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GAYATHRI SANTHOSH |
| Designation |
POST GRADUATE |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY
FATHER MULLER MEDICAL COLLEGE
FATHER MULLER ROAD
KANKANADY
MANGALORE
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9745913530 |
| Fax |
|
| Email |
gayathri.san95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMESHA BHAT M |
| Designation |
PROFESSOR |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY
FATHER MULLER MEDICAL COLLEGE
FATHER MULLER ROAD
KANKANADY
MANGALORE
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9845084224 |
| Fax |
|
| Email |
rameshderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMESHA BHAT M |
| Designation |
PROFESSOR |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY
FATHER MULLER MEDICAL COLLEGE
FATHER MULLER ROAD
KANKANADY
MANGALORE
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9845084224 |
| Fax |
|
| Email |
rameshderma@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIAN ACADEMY OF DERMATOLOGISTS, VENEREOLOGISTS AND LEPROLOGISTS, KARNATAKA |
|
|
Primary Sponsor
|
| Name |
GAYATHRI SANTHOSH |
| Address |
DEPARTMENT OF DERMATOLOGY, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| GAYATHRI SANTHOSH |
FATHER MULLER MEDICAL COLLEGE HOSPITAL |
DERMATOLOGY OPD, GROUND FLOOR, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE 575002,
Dakshina Kannada
KARNATAKA |
9745913530
gayathri.san95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of all age and sex.
2. All the patients with clinical diagnosis of tinea incognito involving the glabrous skin.
|
|
| ExclusionCriteria |
| Details |
1. Patients with other pre-existing skin disorders.
2. Patients with exclusive Tinea Capitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will help us analyse the various clinical presentations & identify the fungal species associated with it. It also shines light on the unregulated sale and unsupervised use of topical steroids and fixed dose combination creams (FDC) containing steroids resulting in a difficult to manage and resistent form of dermatophytosis.
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The results will help us find out the treatment resistent fungal species caused by the unregulated use of steroids. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="71"
Sample Size from India="71"
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)
|
22/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dermatophytosis is a superficial fungal infection of keratinized tissue caused by keratinophilic fungi called dermatophytes. Dermatophytes metabolize dead keratin and evoke an eczematous response. This response leads to a poor supply of keratin to the fungus, thereby limiting the infection. Immunosuppressants such as steroids suppress this protective eczematous response, enhancing fungal growth. Clinically, these lesions have a less raised margin, and are not as scaly as classic dermatophytosis. They tend to be extensive, pruritic, erythematous and pustular, and may mimic other skin diseases.The unregulated sale and erratic , unsupervised use of topical steroids and fixed dose combination creams (FDC) containing steroids are considered prime culprits in the unprecedented epidemic of recalcitrant dermatophytosis on the indian subcontinent as well as in the middle eastern countries.Most FDCs are combinations of two, three, and even four drugs viz. one antifungal agent like, miconazole, clotrimazole, ketoconazole; a potent corticosteroid, the commonest being clobetasol propionate; and one or two antibacterial agents like neomycin, gentamycin etc. A new diagnostic approach using the matrix-assisted laser desorption/ionization-time-of-flight (MALDI-TOF) mass spectrometry (MS)-based strategy has facilitated the effective identification of clinical dermatophyte isolates. |