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CTRI Number  CTRI/2021/01/030753 [Registered on: 27/01/2021] Trial Registered Prospectively
Last Modified On: 22/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to Assess the Effectiveness and Side effects of Naftifine Gel 2% in patients with fungal infection of foot 
Scientific Title of Study   A Phase III, Multi-Center, Double Blind, Comparative, Randomised, Prospective, Parallel Study to evaluate the Efficacy and Safety Naftifine Hydrochloride Gel 2% in patients with Interdigital Tinea Pedis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/NAFITP/10/2019 Version 1.0 Dated 13-Oct-2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Sreenivasa Chary S 
Designation  Deputy General Manager 
Affiliation  Hetero Labs Limited 
Address  Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sreenivasa.chary@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha 
Designation  Senior Vice-President 
Affiliation  Hetero Labs Limited 
Address  Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited 
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad-500018, Telangana, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Rajamma  ACSR Government Medical College and Hospital  Department of Dermatology, Dargamitta, Nellore-524004
Nellore
ANDHRA PRADESH 		 9908773534

avularajamma@gmail.com 
Dr Pranjali Kapoor  Aman Hospital and Research Center  15, Shahswat, Opp E.S.I. Hospital, Gotri Road, Vadodara-390021
Vadodara
GUJARAT 		 9099019599

pranjali.dhebar@yahoo.com 
Dr V Revathi  Government Medical College and Government General Hospital  Department of dermatology, Srikakulam – 532001
Srikakulam
ANDHRA PRADESH 		 9908066043

drrevathivggh@gmail.com 
Dr Bindiya Bansal  Maharaja Agrasen Superspeciality Hospital  Central spine, Agrasen Aspatal Marg, sector 7, Vidhyanagar, Jaipur-302039
Jaipur
RAJASTHAN 		 9765018595

bindubansal06@gmail.com 
Dr Davinder Prasad  Nehru Hospital - PGIMER  Department of Dermatology, Sector12, Chandigarh-160012
Chandigarh
CHANDIGARH 		 9914209560

prasad@me.com 
Dr Denarla Sudha Vani  Osmania General Hospital  Department of Dermatology, 1st floor, Golden Jubilee Block, Afzalgunj, Hyderabad-500012
Hyderabad
TELANGANA 		 9849303221

drsudhavani@gmail.com 
Dr Saswati Halder  School of Tropical Medicine  Department of Dermatology, 108 C R Avenue, Kolkata-700073
Kolkata
WEST BENGAL 		 9434427717

drsaswati_h@yahoo.co.in 
Dr Surendra Kumar  SMS Medical College  Department of Skin, VD and Leprosy, Charak Bhavan, OPD block, JLN Marg, Jaipur-302004
Jaipur
RAJASTHAN 		 9660604041

surenbhu2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, School of Tropical Medicine  Submittted/Under Review 
Ethics Committee, SMS Medical College  Submittted/Under Review 
IEC Maharaja Agrasen Superspeciality Hospital  Approved 
Institutional Ethics Committee, ACSR Government Medical College and Hospital  Submittted/Under Review 
Institutional Ethics Committee, Aman Hospital and Research Centre  Submittted/Under Review 
Institutional Ethics Committee, Government Medical College and Government General Hospital  Approved 
Institutional Ethics Committee, Osmania Medical College  Submittted/Under Review 
Institutional Ethics Committee, PGIMER  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B353||Tinea pedis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Miconazole Gel 2%  Study medication to be applied to the affected and immediate surrounding area (an approximate 1- inch margin of healthy surrounding skin) morning and evening respectively for 14 days 
Intervention  Naftifine Hydrochloride Gel 2%  Study medication to be applied to the affected and immediate surrounding area (an approximate 1- inch margin of healthy surrounding skin) morning and evening respectively for 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Males and females 18-65 years of age
2. Patients with clinical diagnosis of tinea pedis
3. Patients with the sum of the clinical signs and symptoms scores of the target lesion is at least 5(on a scale of 0-3)
4. Patients with mycological diagnosis of interdigital tinea pedis 
 
ExclusionCriteria 
Details  1. Patients with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot
2. Patients with known hypersensitivity to Naftifine and/or to any component of the formulation
3. Patients who are immunocompromised (due to disease (HIV or medications)
4. Patients with uncontrolled diabetes mellitus (HbA1C ≥8) at study entry
5. Patients using the following medications:
- Use of antipruritics, including antihistamines, within 72hours prior to randomization
- Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to randomization
- Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to randomization
- Use of oral terbinafine or itraconazole within 2 months prior to randomization
- Use of immunosuppressive medication or radiation therapy within 3 months prior to randomization 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients achieving clinical cure  Week 6 (± 4 days) (study day 38-46) following 2 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients achieving clinical cure  Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment 
Proportion of patients achieving mycological cure  Week 6 (± 4 days) (study Day 38-46) and at Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment 
Proportion of patients achieving complete clearance  Week 6 (± 4 days) (study day 38-46) and at Week 12 (± 4 days) (study Day 80-88) following 2 weeks of treatment 
Treatment emergent clinical & laboratory adverse events (TEAEs)  All Visits 
 
Target Sample Size   Total Sample Size="224"
Sample Size from India="224" 
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 
Date of First Enrollment (India)   27/01/2021 
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   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is a phase III, double blind, two-arm, randomized, prospective, multi center, efficacy and safety study of Naftifine Hydrochloride Gel 2%, in patients with Interdigital Tinea Pedis. The randomization would be in 1:1 ratio between Naftifine Hydrochloride Gel 2% and Miconazole Gel 2% arms respectively. The primary objective is to evaluate the efficacy of Naftifine Hydrochloride Gel 2% in patients with Interdigital Tinea Pedis and secondary objective is To evaluate the safety and tolerability of Naftifine Hydrochloride Gel 2% in patients with Interdigital Tinea Pedis. The total study duration for each patient would be 13 weeks.
 
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