| CTRI Number |
CTRI/2023/03/050254 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Expression of inflammatory markers in chronic dermatophytosis |
|
Scientific Title of Study
|
An analytical study on the mRNA expression of inflammatory cytokines in chronic dermatophytosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi AR |
| Designation |
Postgraduate-1 |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Dermatology, Yenepoya Medical College Hospital, University road , Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9980532842 |
| Fax |
|
| Email |
swathiar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath Shenoy M |
| Designation |
Professor & HOD |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Dermatology, Yenepoya Medical College Hospital, University road , Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845009976 |
| Fax |
|
| Email |
manjunath576117@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi AR |
| Designation |
Postgraduate-1 |
| Affiliation |
Yenepoya Medical College Hospital |
| Address |
Department of Dermatology,
Yenepoya Medical College Hospital, University road , Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9980532842 |
| Fax |
|
| Email |
swathiar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Yenepoya Medical College |
| Address |
Yenepoya Medical College Hospital, University road, Deralakatte, Mangalore, 575018 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Yashodhar P Bhandary |
Yenepoya Medical College Hospital, University road, Deralakatte, Mangalore, 575018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swathi AR |
Yenepoya Medical College Hospital |
Department of Dermatology,
Yenepoya Medical College Hospital, University road, Deralakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA |
9980532842
swathiar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cases: Patients aged 18 and above visiting OPD of DVL with clinical diagnosis of chronic dermatophytosis
Controls : Age and gender matched healthy volunteers who do not have dermatophytosis |
|
| ExclusionCriteria |
| Details |
For cases and controls :
1)Patients with inflammatory skin or systemic diseases including psoriasis, connective tissue diseases, diabetes, atopic disorders, immunocompromised status and women, who are pregnant or lactating or with other disorders as per judgement by investigators.
2)Patients who have used topical corticosteroids or any form of antifungals in the past 1 month.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will give an account of the various interleukins expressed in the skin in dermatophytosis. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will help widen the knowledge about the immunological response seen in chronic dermatophytosis that may help in designing new interventions in relcalcitrant disease. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/03/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dermatophytosis is a fungal infection of the keratinized structures like stratum corneum of skin, hair and nails. The optimal resolution of dermatophyte infections is associated with effective contributions of Th1 and Th17 responses involving IFN-γ and IL-17A respectively. The infected keratinocytes show increased expression of pro- inflammatory cytokines such as IL-1β, IL-6, IL-8, IL-17 due to the direct action of dermatophytes at the transcriptional level. Deviated response towards Th2 may be associated with chronic dermatophytosis. The study aims to understand the events occurring at the molecular level by determining the mRNA expression of various inflammatory cytokines in chronic dermatophytosis and also comparing their expression in healthy individuals. Biopsies of the lesional skin is subjected to mRNA expression of certain cytokines by polymerase chain reaction and the expression is compared with the skin healthy volunteers. |