| CTRI Number |
CTRI/2020/05/025442 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
16/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effectiveness of Tablet Fluuconazole in superficial fungal infection (Tinea Corporis) |
|
Scientific Title of Study
|
A prospective clinical study to explore the oral Fluconazole resistance in Tinea Corporis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AsviniJ |
| Designation |
MD Pharmacology Ist year Post Graduate , Department of Pharmacology |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
POST GRADUATE ROOM DEPARTMENT OF PHARMACOLOGY, PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,
COIMBATORE,
TAMILNADU
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9750666012 |
| Fax |
|
| Email |
asvinij91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K BHUVANESWARI |
| Designation |
Professor and Head Of The Department of Pharmacology |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Professor and HOD Room Department of Pharmacology
PSG Institute Of Medical sciences and Research
Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9894769934 |
| Fax |
|
| Email |
nandabhuvana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K BHUVANESWARI |
| Designation |
Professor and Head Of The Department of Pharmacology |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Professor and HOD Room Department of Pharmacology
PSG Institute Of Medical sciences and Research
Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9894769934 |
| Fax |
|
| Email |
nandabhuvana@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH PEELAMEDU COIMBATORE 641004 TAMILNADU |
|
|
Primary Sponsor
|
| Name |
Dr ASVINI J |
| Address |
PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH PEELAMEDU COIMBATORE 641004 TAMILNADU |
| 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 |
| ASVINI J |
PSG IMSR |
PSG Institute of Medical Sciences
Peelamedu
Coimbatore
Coimbatore
TAMIL NADU |
9750666012
asvinij91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee PSGIMS R |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Single or multiple annular erythematous plaques
2.KOH mount positive for Tinea corporis
3.No previpous exposure to Fluconazole
4.Comorbidities like Diabetes mellitus, obesity and other endocrine disorders. |
|
| ExclusionCriteria |
| Details |
1.Large cofluent lesions.
2.History of previous exposure to Fluconazole
3.Patients on medications like steroide, antihistamines, aspirin, immunomodulators,statins,NSAIDS.
4.Patients on chronic medications for TB, HIV, Leprosy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical cure of Pruritus,Erythema and Scaling |
At 15th day of Fluconazole Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the resistance of Fluconazole in patients with comorbidities like Diabetes mellitus, obesity and other endocrine disorders |
At 15th day of Fluconazole treatment |
| To study the role of plasma levels of Fluconazole if there is a resistance and no clinical cure with Fluconazole |
HPLC - analysis of Fluconazole levels, skin scrapings-culture |
| To observe the side effects of Fluconazole following administration of Fluconazole |
During the 15 days of Fluconazole therapy |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/05/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction: Dermatophytes are superficial fungal infections that invade and multiply within the keratinised tissues such as skin, hair , nails.worlwide infection with dermatophytes accounts for approximately 25% of infective skin disease. Fluconazole is the the first line treatment of choice for tinea corporis . This study aimed to evaluate the Fluconazole resistance in Tinea corporis and to corelate the peak plasma concentration of Fluconazole and Tinea corporis resistance. Materials and Methodology: sample size of 94 Tinea corporis patients will be recruited to treat with Fluconazole for a period of 15 days .patients will be reviewed at the end of 15 days . If there is a clinical cure and they will be declared as cured andv responded to Fluconazole. If there is no clinical cure and not responded to Fluconazole on 15 th day , peak plasma concentratioin of Fluconazole will be measured using HPLC and skin scraping for fungal culture will be done. Result: Data collection will be statistically analysed by pearson corelation. Conclusion: IHEC approval: This study has been approved by the IHEC of PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH ( affiliated to TN MGR Medical University ), coimbatore Proposal number- 19/330 dt.21.01.2020 |