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CTRI Number  CTRI/2022/04/042183 [Registered on: 26/04/2022] Trial Registered Prospectively
Last Modified On: 19/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare efficacy of itraconazole capsules and super bioavailable itraconazole capsules in treatment of ringworm. 
Scientific Title of Study   Comparative serum and sebum concentrations and efficacy of orally administered conventional itraconazole 100 mg twice daily vs conventional itraconazole 200 mg once daily vs super bioavailable itraconazole 130 mg once daily vs super bioavailable itraconazole 100 mg once daily in subjects with Dermatophytosis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IIT-01-2022, Version-01, dated 20/01/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr prashant kesharwani  
Designation  Assistant Professor  
Affiliation  Jamia Hamdard  
Address  Department of pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard

South
DELHI
110062
India 
Phone  7999710141  
Fax    
Email  prashant@jamiahamdard.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurav Kumar Jain  
Designation  Associate Professor  
Affiliation  Delhi Institute Of Pharmaceutical Sciences And Research  
Address  Gate Number 1, Mehrauli-Badarpur Road, Puspvihar Sector 3, New Delhi

South
DELHI
110017
India 
Phone  9354536454  
Fax    
Email  drgkjain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Payal Gupta 
Designation  student  
Affiliation  Delhi Institute of Pharmaceutical Sciences and Research 
Address  Gate Number 1, Mehrauli-Badarpur Road, Puspvihar Sector 3, New Delhi

South
DELHI
110017
India 
Phone  9891008657  
Fax    
Email  payalsinghal128@gmail.com  
 
Source of Monetary or Material Support  
Scarlet Clinic i 84a, Central Market, Lajpat Nagar II, New Delhi, Delhi 110024 
 
Primary Sponsor  
Name  Scarlet Clinic  
Address  i 84a, Central Market, Lajpat Nagar II, New Delhi 
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 Mukesh Manjhi   Scarlet Clinic   Scarlet Clinic, i 84a, Central Market, Lajpat Nagar II, Lajpat Nagar, New Delhi, Delhi 110024
South
DELHI 		 9958841558

drmukeshmanjhi13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goodsocietyethicalresearch  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B359||Dermatophytosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional itraconazole   100 mg twice daily for 4 weeks  
Comparator Agent  Conventional itraconazole   200 mg once daily for 4 weeks  
Intervention  Super bioavailable itraconazole   100 mg once daily administered before breakfast for 4 weeks  
Intervention  super bioavailable itraconazole   130 mg once daily administered before breakfast for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Subject able to understand and ready to provide written informed consent.
2.Males and females aged ≥18 years, clinically diagnosis for tinea corporis or tinea cruris with clinical score ≥5.
3.Consent of the participating subject to provide photography of the affected area before, during and after the study. 
 
ExclusionCriteria 
Details  1.Subjects not having tinea corporis or tinea cruris infection.
2.Subjects who received any oral or topical tinea treatments, within one week prior to screening or had ingested any drug in the week prior to start or during the treatment, which in the opinion of investigator could compromise the study.
3. Subjects with history of hypersensitivity to study drug, immunocompromised status or superadded bacterial infection.
4. Pregnant or lactating women.
5. Subjects with a serious illness (e.g. diabetes mellitus, collagen diseases, auto-immune diseases, hematological diseases and malignant tumors); and, those with liver dysfunction, kidney dysfunction or cardiac problems.
6.Subjects who received an investigational drug or have participated in a clinical trial within the previous 30 days.
7.Subject has history of drug dependence or excessive alcohol intake on a habitual basis. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Serum itraconazole AUC, trough itraconazole concentrations and sebum concentrations will be assessed . Clinical scoring and lesion photographs will be recorded followed by mycological assessment. Efficacy in terms of a number of patients achieving clinical cure ( No signs or symptoms of tinea infection erythema, scaling, pruritis, and papules, clinical score ≤ 2) or mycological cure (Negative KOH microscopy) at the end of the study.  4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Liver function tests (SGOT and SGPT) will be monitored at baseline and at the end of study.  28 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   02/05/2022 
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="0"
Months="0"
Days="28" 
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   this study is a randomized, open label , parallel group, four arm, single center study comparing serum, sebum concentrations and efficacy of orally administered conventional itraconazole 100 mg twice daily vs conventional itraconazole 200 mg once daily vs super bioavailable itraconazole 130 mg once daily vs super bioavailable itraconazole 100 mg once daily in subjects with Dermatophytosis. patients ( 10 in each treatment group ) complying with the inclusion criteria will be enrolled in the study and baseline clinical score based on erythema, scaling, pruritis, and papules noted and graded on 4 point scale: Score 0=absent, 1=mild, 2=moderate, and 3=severe. Photographs of the lesions will be recorded and skin scraping for KOH smear will be collected for mycological assessment. Subjects were then randomly divided into four treatment groups: (A) Treatment 1: conventional ITZ 100 mg, twice daily; (B) Treatment 2: conventional ITZ 200 mg, once daily; (C) Treatment 3: super bioavailable ITZ 130 mg, once daily and (D) Treatment 4: super bioavailable ITZ 100 mg, once daily .At Day 0 blood samples at 0 min, 0.5, 1, 2, 4, 8, 12 and 24 h from subjects will be collected. Thereafter subjects were followed up at Day 3, Day 7, Day 14 and Day 28 (final visit) for collection of blood and sebum samples. At final visit (Day 28), the Clinical scoring and lesion photographs will be recorded followed by mycological assessment. For safety assessment liver function test will be performed at baseline and final visit. The data will be compared against baseline values of the individual subject and among treatments as per study primary and secondary end points.  
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