| CTRI Number |
CTRI/2021/04/033003 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Clinical and Dermoscopic feature of Fungal infections in children |
|
Scientific Title of Study
|
A STUDY OF CLINICO-DERMOSCOPIC PATTERN OF DERMATOPHYTIC INFECTIONS IN PEDIATRIC PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka wadhwa |
| Designation |
MD post graduate |
| Affiliation |
Maulana azad medical college |
| Address |
Department of dermatology Maulana Azad Medical College 2 bahadur shah zafar marg New delhi
Central
DELHI
110002
India |
| Phone |
7011761472 |
| Fax |
|
| Email |
priyankawadhwa94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KD Barman |
| Designation |
Professor and guide |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of dermatology Maulana Azad Medical College 2 bahadur shah zafar marg New delhi
Central
DELHI
110002
India |
| Phone |
9868961716 |
| Fax |
|
| Email |
kdebbarman@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KD Barman |
| Designation |
Professor and guide |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of dermatology Maulana Azad Medical College 2 bahadur shah zafar marg New delhi
Central
DELHI
110002
India |
| Phone |
9868961716 |
| Fax |
|
| Email |
kdebbarman@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college and associated lok nayak hospital |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka wadhwa |
| Address |
Department of dermatology
Maulana Azad medical college 2 bahadur shah zafar marg new delhi 110002 |
| 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 |
| Dr Priyanka wadhwa |
Lok nayak hospital |
Department of dermatology
Maulana azad medical college
2 bahadur shah zafar marg new delhi 110002
Central
DELHI |
7011761472
priyankawadhwa94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B350||Tinea barbae and tinea capitis, (2) ICD-10 Condition: B354||Tinea corporis, (3) ICD-10 Condition: B356||Tinea cruris, (4) ICD-10 Condition: B355||Tinea imbricata, (5) ICD-10 Condition: B352||Tinea manuum, (6) ICD-10 Condition: B353||Tinea pedis, (7) ICD-10 Condition: B351||Tinea unguium, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All the clinically diagnosed children upto 12-years of age with dermatophytic infections attending dermatology OPD |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of dermatophytic infection in pediatric patients attending Dermatology OPD in LNH, New Delhi |
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the dermoscopic findings of dermatophytic infections in pediatric patients |
10 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/04/2021 |
| 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="0"
Months="11"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It will be a cross sectional study to determine the prevalence and dermoscopic finding of dermatophytic infections in pediatric patients less than 12years of age attending Dermatology OPD. Informed consent will be taken from parents/local guardian after which demographic details and history will be noted in a questionnare. General physical, systemic and muco-cutaneous examination will be done followed by dermoscopy and KOH evaluation of lesion. |