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CTRI Number  CTRI/2025/08/093116 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Study on the safety and effectiveness of econazole capsule in treating fungal skin infections in adults. 
Scientific Title of Study   Repurposing Econazole for the treatment of recalcitrant dermatophytosis, a proof-of-concept study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Nusrat Shafiq  
Designation  Professor  
Affiliation  Postgraduate institute of medical education and research (PGIMER), Chandigarh  
Address  Room No 4017, Department of Pharmacology, 4th floor Research Block b, PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9478000822  
Fax    
Email  nusrat.shafiq.pgi@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Prof Nusrat Shafiq  
Designation  Professor  
Affiliation  Postgraduate institute of medical education and research (PGIMER), Chandigarh  
Address  Room No 4017, Department of Pharmacology, 4th floor Research Block b, PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9478000822  
Fax    
Email  nusrat.shafiq.pgi@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Tarun Narang 
Designation  Additional Professor 
Affiliation  Postgraduate institute of medical education and research (PGIMER), Chandigarh  
Address  Department of Dermatology, Venereology and Leprology, Faculty offices, 2nd floor, Nehru hospital PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9316063166  
Fax    
Email  narangtarun2012@gmail.com  
 
Source of Monetary or Material Support  
Excellion Innovations and Inventions Pvt. Limited (EXII), Chandigarh 
 
Primary Sponsor  
Name  M/S Excellion Innovations and Inventions 
Address  M/S Excellion Innovations and Inventions Pvt. Limited (EXII) 5568, Sector-38 West, Chandigarh-160012 India. 
Type of Sponsor  Other [Innovation Development Company] 
 
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 
Prof Nusrat Shafiq   Postgraduate institute of medical education and research (PGIMER), Chandigarh   Room No. 4017 Department of Pharmacology Sector 12 Chandigarh 160012 India
Chandigarh
CHANDIGARH 		 9478000822

nusrat.shafiq.pgi@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   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 
Intervention  Econazole based regimen  The econazole based regimen will include 500mg econazole once daily for 8 weeks. At 12 weeks, a clinical evaluation will be made for the relapse of infection. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Adult patients of either sex diagnosed with recalcitrant dermatophytosis.
2. Patients diagnosed with recalcitrant dermatophytosis who have demonstrated resistance to two rounds of standard antifungal treatments administered according to the established standard of care, which currently is as follows, Itraconazole 200-400mg/day in Divided doses for 6-8 weeks.
If a woman is of child-bearing age, then proper method of birth control should be followed. Both male and female patients must be advised to use birth control methods during the treatment with bedaquiline.
4. Patients Should be willing to give written informed consent.
5. Patients who are willing to comply with the follow-ups and investigations related to the study.
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity / contraindications to azole group of drugs.
2. Currently on any other antifungal medications (systemic/topical).
3. On corticosteroid therapy in the past two weeks.
4. Requiring prolonged therapy with proton pump inhibitors.
5. Pulmonary/extrapulmonary tuberculosis on treatment with anti-tubercular drug regimen involving rifampicin.
6. Concomitant therapy with carbamazepine, phenobarbitone, phenytoin.
7. On HMG-CoA Reductase Inhibitors like simvastatin, lovastatin.
8. Baseline ALT more than 3 times of upper limit of normal level.
9. On systemic immunosuppressive drugs and immunocompromised patients such as HIV positive/ post-renal transplant.
10. Known heart failure or on any drugs for cardiac arrhythmias
11. Pregnant and lactating females.
12. History of lactose intolerance.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients showing complete cure (clinical + mycological) at the end of 8 weeks of therapy.
2. Proportion of patients remaining relapse free after 8 weeks of therapy.
 		 8 Weeks and 12 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 after 8 weeks of therapy.
4. Correlation of drug levels in plasma and sebum with Total Symptom Score at week-4 & 8.
 		 2 Weeks,4 Weeks,8 Weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/09/2025 
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="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  

India is currently facing a surge in recalcitrant dermatophytosis - chronic, recurrent fungal infections where failure of response to commonly used antifungals like itraconazole and terbinafine is often encountered. This resistance is driven by factors such as misuse of steroid-antifungal creams, environmental changes, and the rise of resistant strains like Trichophyton mentagrophytes. Econazole, an imidazole antifungal, has shown broad-spectrum activity and was found to be safe in earlier studies on healthy volunteers. However, its clinical use has been limited to topical forms, which suffer from poor skin penetration and short retention. This will be an open-label, investigator-initiated, academic proof-of-concept study designed to evaluate the safety and effectiveness of oral econazole in patients who have failed to respond to at least two previous courses of standard antifungal treatment. The study will assess complete cure rates (clinical and mycological) at 8 weeks, treatment-emergent adverse events, relapse at 12 weeks, and correlation of plasma and sebum drug levels.

 
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