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CTRI Number  CTRI/2020/10/028565 [Registered on: 22/10/2020] Trial Registered Prospectively
Last Modified On: 21/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study to compare effectiveness and safety of super bioavailable itraconazole capsules and itraconazole capsules in treatment of ringworm 
Scientific Title of Study   An open label, prospective, double arm clinical trial to compare the efficacy and safety of super bioavailable itraconazole capsules and itraconazole capsules in the management of corporis/cruris/faciei. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjunath Shenoy 
Designation  Consultant Dermatologist 
Affiliation  Omega Hospital 
Address  Room No. 1, Department of dermatology, Mahaveera Circle, Kankanady, Mangalore, Karnataka 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845009976   
Fax    
Email  manjunath576117@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjunath Shenoy 
Designation  Consultant Dermatologist 
Affiliation  Omega Hospital 
Address  Room No. 1, Department of dermatology, Mahaveera Circle, Kankanady, Mangalore, Karnataka 575002


KARNATAKA
575002
India 
Phone  9845009976   
Fax    
Email  manjunath576117@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manjunath Shenoy 
Designation  Consultant Dermatologist 
Affiliation  Omega Hospital 
Address  Room No. 1, Department of dermatology, Mahaveera Circle, Kankanady, Mangalore, Karnataka 575002


KARNATAKA
575002
India 
Phone  9845009976   
Fax    
Email  manjunath576117@gmail.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited Glenmark House BD Sawant Marg Andheri East Mumbai 400099  
 
Primary Sponsor  
Name  Omega Hospital 
Address  Mahaveera Circle, Kankanady, Mangalore, Karnataka 575002 
Type of Sponsor  Private hospital/clinic 
 
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 Manjunath Shenoy  Omega Hospital  Mahaveera Circle, Kankanady, Mangalore, Karnataka 575002
Dakshina Kannada
KARNATAKA 		 9845009976

manjunath576117@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Omega Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B354||Tinea corporis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Itraconazole  100 mg capsule twice daily administered with food 
Comparator Agent  Super bioavailable itraconazole  50 mg capsule twice daily administered with food 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Both male and female patients aged ≥ 18 years and ≤ 60 years.
2. Patients with diagnosis of tinea corporis/cruris/faciei requiring systemic antifungal therapy.
3. Female of child bearing potential, who is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives).
4. 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.
5. 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. Patients with malignancy.
11. Any patient whom the investigator judged to be inappropriate for this study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy assessments evaluation of fungal score consisting of lesional scoring and clinical severity scoring. Lesional scoring includes symptoms such as scaling, erythema, pruritus and lesion margin continuity and elevation. Clinical severity score body surface area (BSA) covered by the lesions.
Mycological cure will be assessed by doing KOH microscopy of sample of each patient at the start and end of the therapy.
 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Safety will be assessed by monitoring the following parameters for all the patients
The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal will be summarized by treatment groups.
 		 4 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   26/10/2020 
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 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is designed as open label, prospective, randomized, comparative, double arm, single center study to evaluate the efficacy, safety and tolerability of super bioavailable itraconazole in comparison with conventional itraconazole in patients with tinea corporis/cruris/faciei. Total 70 patients will be enrolled in the study , 35 in each arm and will be instructed about the dosage of the drugs. The patient would be called for regular follow up as per the schedule predefined in the protocol. At the end of study all the patients will be evaluated. 
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