| CTRI Number |
CTRI/2025/03/083158 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Skin Fungal Infections in Children: A Study of Symptoms, Appearance, and Tests |
|
Scientific Title of Study
|
EVALUATION OF CLINICAL, DERMOSCOPIC, AND MYCOLOGICAL PATTERNS OF DERMATOPHYTOSIS IN CHILDREN |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PENUMATSA PRIYANKA |
| Designation |
post graduate student |
| Affiliation |
GSL Medical college and general hospital |
| Address |
GSL Medical college and General Hospital,NH16,Lakshmipuram,
Rajamahendravaram
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7997592345 |
| Fax |
|
| Email |
drpriyankap1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUBHASHINI KONALA |
| Designation |
ASSOCIATE PROFESSOR,DEPARTMENT OF DVL,GSL MEDICAL COLLEGE |
| Affiliation |
GSL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
GSL Medical college and General Hospital,NH16,Lakshmipuram,
Rajamahendravaram
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9985566999 |
| Fax |
|
| Email |
subha.konala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PENUMATSA PRIYANKA |
| Designation |
post graduate student |
| Affiliation |
GSL Medical college and general hospital |
| Address |
GSL Medical college and General Hospital,NH16,Lakshmipuram,
Rajamahendravaram
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7997592345 |
| Fax |
|
| Email |
drpriyankap1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSL Medical College and General Hospital,NH16,Rajamahendravaram-533296 |
|
|
Primary Sponsor
|
| Name |
GSL MEDICAL COLLEGE |
| Address |
GSL Medical College and General Hospital,Lakshmipuram,NH16,Rajamahendravaram-533296 |
| Type of Sponsor |
Private medical college |
|
|
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 Penumatsa Priyanka |
GSL General Hospital |
Room no.4,Department of DVL,Lakshmipuram,NH16,Rajamahendravaram-533296
East Godavari
ANDHRA PRADESH |
7997592345
drpriyankap1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,GSL Medical College and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with dermatophytosis under age of 18 years.
2)Patients who were not on antifungals, topical and/or Oral in the last 2 weeks.
|
|
| ExclusionCriteria |
| Details |
1)Patients above the age of 18 years.
2)Patients who were on antifungals in the last 2 weeks.
3)Parents not willing for consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will give information about Clinical, Dermoscopic and Mycological patterns of dermatophytosis in children in our region. |
Dermoscopy pictures will be taken in 1 day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Clinical, Dermoscopic and Mycological patterns of dermatophytosis in children in our region, thus helping in early diagnosis and management of dermatophytosis in children and obviating the need of cumbersome lab procedures. |
Fungal culture - 4weeks |
|
|
Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
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)
|
03/04/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dermatophytosis is
prevalent as an epidemic in our country and its menace is growing day by day. There has been an increased incidence and prevalence along with a change
in the spectrum of isolates since the past decade. Children are particularly susceptible to
dermatophytic infections due to their comparatively lower immunity and other
factors like poor personal hygiene habits, lack of health awareness and poor
environmental sanitation.Very few studies were available globally and in
India, and those studies were done only on clinical and mycological features
but not about the dermoscopic findings of dermatophytosis in children. This
study is inclined towards the identification of the morphology of lesions, the
prevalence of species of the isolated causative dermatophytes among children in
our area, and the observation of dermoscopic findings in different clinical
morphological patterns and species. So, this study will add value to the early
diagnosis and management of dermatophytosis in children. |