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CTRI Number  CTRI/2019/04/018560 [Registered on: 11/04/2019] Trial Registered Prospectively
Last Modified On: 09/08/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of efficacy and safety of Itraconazole capsule and Amorolfine cream in skin infections 
Scientific Title of Study   An open label, prospective, observational, non-comparative, single arm clinical trial to evaluate the efficacy and safety of combination therapy with oral Itraconazole and topical Amorolfine in management of dermatophytosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishalskshi Viswanath 
Designation  Associate Professor and Head of Department, 
Affiliation  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital 
Address  Department of Dermatology Rajiv Gandhi Medical College & CSMH Kalwa Thane Municipal Corporation Maharashtra

Thane
MAHARASHTRA
400605
India 
Phone  9324086679  
Fax    
Email  drvishalakshiviswanath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishalskshi Viswanath 
Designation  Associate Professor and Head of Department, 
Affiliation  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital 
Address  Department of Dermatology Rajiv Gandhi Medical College & CSMH Kalwa Thane Municipal Corporation Maharashtra

Thane
MAHARASHTRA
400605
India 
Phone  9324086679  
Fax    
Email  drvishalakshiviswanath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishalskshi Viswanath 
Designation  Associate Professor and Head of Department, 
Affiliation  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital 
Address  Department of Dermatology Rajiv Gandhi Medical College & CSMH Kalwa Thane Municipal Corporation Maharashtra

Thane
MAHARASHTRA
400605
India 
Phone  9324086679  
Fax    
Email  drvishalakshiviswanath@gmail.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited Glenmark House BD Sawant Marg Andheri East Mumbai 400099  
 
Primary Sponsor  
Name  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital  
Address  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital Thane Municipal Corporation Kalwa Thane 400605  
Type of Sponsor  Government 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 
Dr Vishalakshi Viswanath  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital  Department of Dermatology, Room No 5, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane Municipal Corporation, Kalwa, Thane, 400605
Thane
MAHARASHTRA 		 9324086679

drvishalakshiviswanath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
Type  Name  Details 
Intervention  combination of oral Itraconazole and topical Amorolfine   Itraconazole 100 mg twice daily for 4 weeks Topical Amorolfine cream 0.25% applied topically twice daily for 6 weeks  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Both male and female patients aged ≥ 18 years and ≤ 60 years.
2. Patients with multi-site, multi-legional dermatophytic infection (tinea infection).
3. Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
4. Patients who the study staff deems reliable and mentally competent to carry out the study.
 
 
ExclusionCriteria 
Details  1. Pregnant or nursing females.
2. Patients with known hypersensitivity to the study drugs.
3. Patients with immunosuppressive disease or on immunosuppressive drugs.
4. Patients with liver dysfunction.
5. Patients with a history of seizures
6. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
7. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
8. History of drug or alcohol dependency or abuse within approximately the last 2 years.
9. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
10. Any patient whom the investigator judged to be inappropriate for this study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy endpoint will be total no. of patients achieving complete cure. (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy)  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. No. of patients achieving clinical cure. (Clinical cure is defined as clear or almost clear symptoms [scaling, pruritus, erythema and incrustation] at the end of therapy)
2. No. of patients achieving mycological cure. (Mycological cure is defined as negative microscopy under potassium hydroxide (KOH) examination at the end of therapy.)
3. Improvement in each symptom from baseline in each visit.
 		 6 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/04/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is an open label, prospective, observational, non-comparative, single arm clinical trial to evaluate the efficacy of combination of itraconazole and amorolfine in patients with multi-site or multi-lesional dermatophytosis. The study will be conducted for 6 weeks on male and female patients aged ≥ 18 years and ≤ 60 years . 

Itraconazole will be given in a dose of 100 mg/day orally for period of 4 weeks, while amorolfine 0.25% will be applied topically twice daily for a period of 6 weeks. The patients would be called for regular follow up as per the schedule.


 
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