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CTRI Number  CTRI/2024/05/066681 [Registered on: 02/05/2024] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Efficacy and safety of itraconazole, SUBA-itraconazole and voriconazole in Recalcitrant Dermatophytosis. 
Scientific Title of Study   Comparative efficacy and safety of itraconazole, SUBA-itraconazole, and voriconazole in the treatment of recalcitrant dermatophytosis – A randomized, open label, active comparator clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nusrat Shafiq 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room number: 4017, Level-4, Research Block-B, PN Chuttani Block, Department of Pharmacology, PGIMER Chandigarh, Sector-12 CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  9478000822  
Fax  172-2744401  
Email  nusrat.shafiq.pgi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nusrat Shafiq 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Room number: 4017, Level-4, Research Block-B, PN Chuttani Block, Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector-12 CHANDIGARH


CHANDIGARH
160012
India 
Phone  9478000822  
Fax  172-2744401  
Email  nusrat.shafiq.pgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  MAHESH KUMAR B 
Designation  Senior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Room number-4019, Research Block -B, Level-4, PN Chuttani Block, Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  8778282202  
Fax    
Email  maheshiva.feb16@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Dector-12, Chandigarh, India. PIN: 160012 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Nusrat Shafiq  PGIMER Chandigarh  Room number: 4017, Level-4, Research Block-B, PN Chuttani Block, Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, Sector-12 CHANDIGARH
Chandigarh
CHANDIGARH 		 9487000822
172-2744401
nusrat.shafiq.pgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural), PGIMER Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B358||Other dermatophytoses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ITRACONAZOLE  200 MG OD, given per oral for a period of 8 weeks 
Comparator Agent  SUBA-ITRACONAZOLE (Super Bioavailable Itraconazole)  130mg OD, given per oral for a period of 8 weeks 
Comparator Agent  VORICONAZOLE  400 MG OD, given per oral for a period of 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with recalcitrant dermatophytosis (persistent disease with duration ranging 6 months to 1 year / encountered reoccurrence of the disease within ≤ 6 weeks of completion of the treatment) of either sex between 18-70 years of age.

2. Patient willing to participate in the study by giving informed written consent.
 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity / contraindications to azole group of drugs.
2. Patients currently on any other antifungal medications (systemic/topical).
3. Patients on topical corticosteroid therapy in the past two weeks.
4. Patients on/ requiring prolonged therapy with proton pump inhibitors.
5. Patients with pulmonary/extrapulmonary tuberculosis on treatment with anti-tubercular drug regimen involving rifampicin.
6. Patients with concomitant therapy with carbamazepine, phenobarbitone, phenytoin.
7. Patients on HMG-CoA Reductase Inhibitors like simvastatin, lovastatin.
8. Patients with baseline ALT more than 3 times of upper limit of normal level.
9. Patients on systemic immunosuppressive drugs and immunocompromised patients such as HIV positive/ post-renal transplant.
10. Patients with known heart failure or on any drugs for cardiac arrhythmias
11. Pregnant and lactating females.
12. Patients with history of lactose intolerance.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• Proportion of patients showing complete cure ( clinical + mycological) at the end of 8 weeks of therapy.
-Clinical cure is defined as Score - 0 in Total Symptom Score.16
-Mycological cure is defined as negative KOH mount at the end of 8 weeks of therapy 		 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of treatment emergent adverse events.
2. Proportions of patients showing clinical cure or mycological cure at the end of 8 weeks of therapy
3. Proportion of patients remaining relapse free for 3 months after 8 weeks of therapy (only in case of completely cured patients).
4. Correlation of drug levels in plasma and sebum with Total Symptom Score at week-4 & 8.
5. Correlation of Serum IL-17 and IgE levels with respect to Total Symptom Score at the end of therapy.
6. Correlation of population pharmacokinetics with the Total Symptom Score at the end of therapy.
 		 8 weeks 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/05/2024 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Background Justification: 
Till date, no robust clinical trials are available to establish the superiority of SUBA- itraconazole over itraconazole and voriconazole in terms of better cure rate or lower relapse rate in the management of dermatophytosis.
Research Question
How does SUBA-itraconazole compare with itraconazole and voriconazole in terms of efficacy, safety and pharmacokinetics.
Objectives:
Primary objective:
To evaluate the efficacy of SUBA-itraconazole vs itraconazole vs voriconazole in the treatment of recalcitrant dermatophytosis
Secondary objectives:
1.To evaluate the safety of SUBA-itraconazole vs itraconazole vs voriconazole in the treatment of recalcitrant dermatophytosis.
2. To evaluate the population pharmacokinetic parameters and sebum concentration of SUBA-itraconazole, itraconazole and voriconazole.
3. To evaluate the role of IL-17 and IgE as immunological markers in recalcitrant dermatophytosis

Endpoints:

Primary endpoint:

1. Proportion of patients showing complete cure ( clinical + mycological) at the end of 8 weeks of therapy

Clinical cure is defined as Score - 0 in Total Symptom Score.

Mycological cure is defined as negative KOH mount at the end of 8 weeks of therapy.

Secondary endpoints;

1. Incidence of treatment emergent adverse events.

2. Proportions of patients showing clinical cure or mycological cure at the end of 8 weeks of therapy

3. Proportion of patients remaining relapse free for 3 months after 8 weeks of therapy (only in case of completely cured patients).

4. Correlation of drug levels in plasma and sebum with Total Symptom Score at week-4 & 8.

5. Correlation of Serum IL-17 and IgE levels with respect to Total Symptom Score at the end of therapy.

6. Correlation of population pharmacokinetics with the Total Symptom Score at the end of therapy.

 

 
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