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CTRI Number  CTRI/2018/04/013045 [Registered on: 04/04/2018] Trial Registered Prospectively
Last Modified On: 04/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study of skin features, laboratory features and response to treatment to antifungal drugs in patients with superficial fungal infections. 
Scientific Title of Study   A Clinico-Mycological, Therapeutic and Antifungal drug sensitivity study of Extensive dermatophytosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vanapalli Ramani Sneha 
Designation  Post graduate Student, MD (DVL) 
Affiliation  Maharajahs Institute Of Medical Sciences 
Address  Department of Dermatology, OP room no: 1, Nellimarla, Vizianagaram, Andhra Pradesh, India.

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  7013763469  
Fax    
Email  sneha.vanapalli8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR T Narayana Rao 
Designation  HOD and Professor of Dermatology (DVL) 
Affiliation  Maharajahs Institute Of Medical Sciences 
Address  Department of Dermatology( DVL), OP room no:1, Nellimarla, Vizianagaram, Andhra Pradesh, India.

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  9849129912  
Fax    
Email  tnr_derma@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vanapalli Ramani Sneha 
Designation  Post graduate Student, MD DVL 
Affiliation  Maharajahs Institute Of Medical Sciences 
Address  Department of Dermatology, OP room no:1, Nellimarla, Vizianagaram, Andhra Pradesh, India.

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  7013763469  
Fax    
Email  sneha.vanapalli8@gmail.com  
 
Source of Monetary or Material Support  
Maharajahs Institute Of Medical Sciences, Nellimarla, Vizianagaram, Andhra Pradesh, India. Pincode: 535217 
 
Primary Sponsor  
Name  MAHARAJAHS INSTITUTE OF MEDICAL SCIENCES 
Address  NELLIMARLA, VIZIANAGARAM (DIST), ANDHRA PRADESH. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
VANAPALLI RAMANI SNEHA  MAHARAJAHS INSTITUTE OF MEDICAL SCIENCES  Department of DVL, Unit 1, OP room no: 1, , NELLIMARLA, VIZIANAGARAM, ANDHRA PRADESH.
Vizianagaram
ANDHRA PRADESH 		 7013763469

sneha.vanapalli8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Maharajahs Institute Of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  EXTENSIVE DERMATOPHYTIC INFECTIONS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GRISEOFULVIN  Group B – Griseofulvin 10 mg/kg Body weight once daily for a period of 6 weeks 
Comparator Agent  GRISEOFULVIN AND TERBINAFINE  Group D – Griseofulvin 10mg / kg BW and Terbinafine 5 mg/kg BW once daily for a period of 6 weeks 
Intervention  ITRACONAZOLE  Group A - systemic Itraconazole 5 mg/kg body weight (BW) once daily for a period of 6 weeks. 
Comparator Agent  ITRACONAZOLE AND GRISEOFULVIN  Group E- Itraconazole 5 mg/kg BW and Griseofulvin 10 mg/kg BW once daily for a period of 6 weeks 
Comparator Agent  TERBINAFINE  Group C- Terbinafine5 mg /kg body weight once daily for a period of 6 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed cases of extensivedermatophytoses infection affecting more than one region of the body.
2. Both sexes between the age groups 18 - 70 yrs
3.Patients who have not used topical and systemic antifungal drugs for the past 6 weeks.
 
 
ExclusionCriteria 
Details  1.Infants, below 18 yrs, above 70 yrs
2.Immunocompromised patients including HIV are excluded.
3.Pregnancy and lactating patients are excludued.
4.Patients receiving multiple drugs for medical conditions including glucocorticosteroids.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Cinical profile of dermatophytic infections prevalent in this region will be noted.
2. Mycological profile of dermatophytic infections including species identification prevalent in this region will be noted.
3. Sensitivity pattern of isolates against terbinafine, itraconazole,griseofulvin will be studied and recorded.
4. Therapeutic efficacy of single and in combinations of systemic antifungal drugs in extensive dermatophytic infections will be reported.

 		 8 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To note the recurrences in the follow up period of 6 months.  6 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)   09/04/2018 
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="30" 
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   This study is a randomised, double blind, parallel group, multi arm trial comparing the therapeutic efficacy of anti fungal drugs in extensive dermatophytic infections. A detailed history and clinical examination will be done. In all suspected cases of dermatophytic infections, specimen for direct microscopy will be collected by scraping the active edge of the affected skin. Material will be subjected to direct microscopic examintaion using 10%KOH. A part of the collected specimen will be sent for fungal culture in sterile specimen bottle. For primary isolation, Sabourads dextrose agar slopes will be used and Dermatophyte test medium will be used as selective medium. Species identification will be done by colony morphology and microscopy on Lactophenol cottobn blue mount. Antifungal drug sensitivity testing will be done by Broth microdilution test using Clinical and laboratory standard institute M38-A standards. All KOH positive cases will be divided into 5 groups of 30 each by randomistaion using computer based softwares and are given systemic antifungals to know the therapeutic efficacy after 6 weeks.

 
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