| CTRI Number |
CTRI/2023/02/049755 [Registered on: 15/02/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Detection of Dermatophytes in Skin and Nails |
|
Scientific Title of Study
|
Detection of Dermatophyte in Sub-clinically Involved Nails by PCR in Patients With Skin Dermatophytosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daya Babu |
| Designation |
Post graduate |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Floor no 5, B block, Department of Dermatology
PSG Institute of
Medical Sciences and Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India
Coimbatore TAMIL NADU 641004 India |
| Phone |
8075494487 |
| Fax |
|
| Email |
dayababu003@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Daya Babu |
| Designation |
Post graduate |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Floor no 5, B block, Department of Dermatology
PSG Institute of
Medical Sciences and Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India
Coimbatore TAMIL NADU 641004 India |
| Phone |
8075494487 |
| Fax |
|
| Email |
dayababu003@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Daya Babu |
| Designation |
Post graduate |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Floor no 5, B block, Department of Dermatology
PSG Institute of
Medical Sciences and Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India
Coimbatore TAMIL NADU 641004 India |
| Phone |
8075494487 |
| Fax |
|
| Email |
dayababu003@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Institute of
Medical Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Reena Rai |
| Address |
Floor no 5, B block, Department of Dermatology PSG Institute of
Medical Sciences and Research, Peelamedu, Coimbatore |
| 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 |
| Reena Rai |
PSG Institute of Medical Sciences and Research |
Floor no 5, B block, Department of Dermatology PSG Institute of
Medical Sciences and Research, Peelamedu, Coimbatore Coimbatore TAMIL NADU |
9894160713
drreena_rai@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee,PSGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L08||Other local infections of skin andsubcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with skin scrapings showing KOH positive for dermatophytes
Patients who are having a visibly un-affected nail
|
|
| ExclusionCriteria |
| Details |
Patients whose skin scrapings are showing KOH negative for dermatophytes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To detect the presence of Dermatophyte in a clinically unaffected nail by PCR in patients with dermatophytic infection of the skin
|
At first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the type of dermatophyte involved |
At first visit |
|
|
Target Sample Size
|
Total Sample Size="108" Sample Size from India="108"
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)
|
25/02/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dermatophytic infection of skin has become an
increasing and common problem in population and are found in keratinized layers
of skin, nail and hair causing superficial mycoses. Dermatophytic infection of skin
is easy to diagnose clinically and microbiological diagnosis is important to
confirm the etiology before starting the treatment. Diagnosis can be confirmed
by microscopy and culture. Microscopic examination of the skin scrapping and
the nail can be performed as an outpatient basis but has low sensitivity. Culture of the fungus takes 4-6 weeks because of the slow growth of the
organism. Molecular methods using RTPCR
has been developed to overcome this problem. The dermatophyte can rapidly be
diagnosed by RT-PCR as they have the advantage of high sensitivity and
specificity and faster turnaround time over the other conventional methods and
is more accurate for the diagnosis.
Patients with extensive dermatophytic infection of the
skin can have dermatophytes in the nails due to chronic itching which can be
easily missed on clinical examination. These patients may not respond to
treatment with conventional dose and duration of antifungals used and they may
have periodic recurrences.
In such patients, microscopy with potassium hydroxide
(KOH) and culture may not reveal the dermatophytes due to poor sensitivity,
specificity and so, the detection of the dermatophytes in the nails are often
missed.
In such patients, PCR being more sensitive and
specific can be a better technique to detect the fungus in the nail.
So, we plan to conduct a study to detect dermatophytes
in patients with uninvolved nails by PCR in people who are having KOH-positive
skin dermatophyte infection. |