| CTRI Number |
CTRI/2024/02/062590 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Comparitive study |
| Study Design |
Other |
|
Public Title of Study
|
Usefulness of Artificial Intelligence in the detection of skin surface fungal infections
|
|
Scientific Title of Study
|
Comparative Trial Of Manual Vs Automated Artificial Intelligence Assisted Detection Of Fungal Elements In Patients With Dermatophytic And Pityriasis Versicolor Infection Using KOH Smear And Direct Blue Is Dye In A Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhukara J |
| Designation |
Associate Professor |
| Affiliation |
St. John’s Medical College |
| Address |
:Department of Dermatology, St. John’s medical college hospital,Bangalore , India
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065029 |
| Fax |
|
| Email |
madhukara.j@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathibha JP |
| Designation |
Assistant Professor |
| Affiliation |
St. John’s Medical College |
| Address |
Department of Dermatology, St. John’s medical college hospital,
Bangalore , India
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065029 |
| Fax |
|
| Email |
prathibha.jp@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathibha JP |
| Designation |
Assistant Professor |
| Affiliation |
St. John’s Medical College |
| Address |
Department of Dermatology, St. John’s medical college hospital,
Bangalore , India
KARNATAKA
560034
India |
| Phone |
08022065029 |
| Fax |
|
| Email |
prathibha.jp@stjohns.in |
|
|
Source of Monetary or Material Support
|
| Bigtec Pvt Ltd, Bangalore |
|
|
Primary Sponsor
|
| Name |
Bigtec Pvt Ltd, Bangalore |
| Address |
2nd Floor, Golden Heights, 59th C Cross, 4th M Block, Rajajinagar, Bangalore - 560010 |
| Type of Sponsor |
Other [Industrial] |
|
|
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 Madhukara J |
St. John’s Medical College Hospital |
St. John’s medical college hospital,
Bangalore , India 560034
Bangalore
KARNATAKA |
08022065029
madhukara.j@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St. John’s Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
To compare the sensitivity of manual (using it as gold standard) vs automated AI assisted method to detect fungal elements in patients with signs and symptoms suggestive of dermatophytic and Pityriasis Versicolor infection using smears stained with KOH stain
Compare the sensitivity of manual vs automated AI assisted method in the detection of fungal elements using smear stained with Direct Blue IS dye.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of positive detection of fungal elements by the method utilizing Artificial Intelligence compared to that of manual detection of fungal elements |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="315"
Sample Size from India="315"
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)
|
01/03/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In this study we intend to evaluate the performance of Artificial intelligence in the detection of skin surface fungal infections from the KOH smear of skin, hair and nail scraping materials which are used for confirmation of dermatophytic infection and pityriasis versicolor in clinically suspected patients. |