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CTRI Number  CTRI/2022/03/041466 [Registered on: 30/03/2022] Trial Registered Prospectively
Last Modified On: 05/09/2022
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 efficacy and safety of Naftifine cream in patients with superficial fungal infection of skin 
Scientific Title of Study   A prospective, randomized, two-arm, double-blind, active-controlled, parallel, multicentre, non-inferiority, phase III clinical trial to assess the efficacy and safety of Naftifine hydrochloride cream 2% w/w as compared to Terbinafine hydrochloride cream 1% w/w in patients with superficial fungal infection of the skin 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No. 21-12 Version: 00 Date: 23/Nov/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravindra Mittal 
Designation  Medical Advisor & Head-Regulatory Affairs 
Affiliation  Zydus Healthcare Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar Highway, Ahmedabad, Gujarat, India

Ahmadabad
GUJARAT
382481
India 
Phone  07948041430  
Fax  079-48041500  
Email  r.mittal@zyduscadila.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pavankumar Daultani 
Designation  Deputy General Manager-New Product Development 
Affiliation  Zydus Healthcare Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar Highway, Ahmedabad, Gujarat, India

Ahmadabad
GUJARAT
382481
India 
Phone  8511697284  
Fax    
Email  pavankumar.daultani@zyduscadila.com  
 
Details of Contact Person
Public Query  
Name  Dr Pavankumar Daultani 
Designation  Deputy General Manager-New Product Development 
Affiliation  Zydus Healthcare Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar Highway, Ahmedabad, Gujarat, India

Ahmadabad
GUJARAT
382481
India 
Phone  8511697284  
Fax    
Email  pavankumar.daultani@zyduscadila.com  
 
Source of Monetary or Material Support  
Zydus Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481, Gujarat, India. Phone No.: 079-48040000 Fax No.: 079-48041500 
 
Primary Sponsor  
Name  Zydus Healthcare Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej-Gandhinagar Highway, Ahmedabad-382481, Gujarat, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Clinical Research Network India CRO  B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi-NCR, Uttar Pradesh 201305  
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ipsa Pandya   Aatman Hospital  Ground Floor, Aatman Hospital, 5, Anveshan Row House, Opp. Bopal Garn BRTS, Bopal- Ghuma Road, Bopal, Ahmedabad-380058, Gujrat
Ahmadabad
GUJARAT 		 9904704445

cr.aatman@gmail.com 
Dr V Revathi  Govt. Medical College Govt.General Hospital Balaga Srikakulam   Dep. of Dermatology,Govt. Medical College Govt.General Hospital Balaga Srikakulam Andhra Pradesh - 532001 India
Srikakulam
ANDHRA PRADESH 		 9908066043

drrevathivggh@gmail.com 
Dr Nibedita Patro  Hi-Tech Medical College & Hospital  Dept. of Dermatology, Hi-Tech Medical College & Hospital, Pandara, Rasulgarh, Bhubaneswar, Odisha-751025
Baleshwar
ORISSA 		 9937740401

nibeditapatro@gmail.com 
Dr Raj Kumar Kothiwal   Jawahar Lal Nehru Medical College & Hospital  Department of Dermatology, Jawahar Lal Nehru Medical College & Hospital, Kala Bagh, Ajmer-305001, Rajasthan
Ajmer
RAJASTHAN 		 9414118811

clinical.jln@gmail.com 
Dr Prerna R Suryatale  Jeevan Rekha Hospital  Jeevan Rekha Hospital, 1st floor, Dr. B.R Ambedkar Road, Opp. Civil Hospital, Veer Chambers, Belagavi(Belgaum)-590002, Karnataka
Belgaum
KARNATAKA 		 7766984722

dr.Prernasuryatale@gmail.com 
Dr Nadia Zakir Main  Prakhar Hospital Pvt Ltd  Dept. Of Dermatology,Prakhar Hospital Pvt Ltd, 8/219 Arya Nagar, Kanpur, Uttar Pradesh-208002
Kanpur Nagar
UTTAR PRADESH 		 7880668537

dr.nadiazakirmain@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee Of The Prakhar Hospital   Approved 
Institute Ethics Committee  Approved 
Institute Ethics Committee Hi Tech Medical College & Hospital  Approved 
Institute Ethics Committee Jawahar Lal Nehru Medical College, Rajasthan  Approved 
Institutional Ethics Committee Aatman Hospital  Approved 
Institutional Ethics Committee at Jeevan Rekha Hospital Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Naftifine hydrochloride cream 2% w/w  Patients will be instructed to apply the allocated medication once daily for 2 weeks treatment period. 
Comparator Agent  Terbinafine hydrochloride cream 1% w/w  Patients will be instructed to apply the allocated medication once daily for 2 weeks treatment period  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either gender of 18 to 65 years of age (both inclusive) 2. Patients with acute symptomatic tinea corporis or tinea cruris limited to single body region and with limited involvement i.e., < 5 skin lesions with each having greatest diameter of < 5 cm
3. Mycological diagnosis of tinea corporis or tinea cruris confirmed by detection of fungal hyphae on a microscopic KOH test
4. Patients with total clinical score of at least 5
5. Patients willing to provide written informed consent and comply with the
protocol requirements 
 
ExclusionCriteria 
Details  1. Patients with history of hypersensitivity to naftifine or terbinafine
2. Patients with extensive or disseminated tinea infections
3. Patients with tinea infection other than tinea corporis or tinea cruris such as tinea infection of face, scalp or feet
4. Patients with diagnosis of tinea infection requiring systemic treatment according to the severity of lesion as judged by the investigator
5. Patients having skin lesions with secondary bacterial infection
6. Patients with other dermatological conditions which may confound the disease assessment and treatment evaluation e.g., contact dermatitis, atopic dermatitis, psoriasis, urticaria
7. Patients with clinically significant uncontrolled systemic diseases such as
gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine or
hematological disorders or malignancy
8. Patients with immunosuppressive disorder e.g., HIV infection or patients on immunosuppressive medications e.g., systemic corticosteroids or cytotoxic drugs
9. Patients with hepatic dysfunction (serum transaminases >_ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine >_ 2.5 mg/dl)
10. Patients who have used the following medications:
a. Topical antifungal agent within 30 days prior to enrollment
b. Systemic antifungal agent within 8 weeks (8 months for oral terbinafine) prior to enrollment
c. Topical corticosteroid on the affected area(s) within 30 days prior to enrollment
d. Systemic corticosteroids within 30 days prior to enrollment
e. Systemic antihistamine agent within 3 days prior to enrollment
f. Any other topical treatment on the affected area(s) within 7 days prior to enrollment
11. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
12. Patients with history of alcohol and/or drug abuse
13. Participation in another clinical trial in the past 3 months prior to screening
14. Any other reason for which the investigator feels that the patient should not participate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical cure at the end of the treatment  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy:
1.Mycological cure at the end of the treatment
2.Composite cure at the end of the treatment
3.Global assessment of efficacy at the end of the treatment
4.Clinical and mycological relapse during the post-treatment follow-up
Safety:
1.Adverse events reported during the study
2.Serious adverse events reported during the study
3.Overall tolerability evaluation at the end of the treatment 		 2 & 4 weeks 
 
Target Sample Size   Total Sample Size="268"
Sample Size from India="268" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="268" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/03/2022 
Date of Study Completion (India) 21/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A prospective, randomized, two-arm, double-blind, active-controlled, parallel, multicentre, non-inferiority, phase III clinical trial.
Study Groups Test drug: Naftifine hydrochloride cream 2% w/w & Reference drug: Terbinafine hydrochloride cream 1% w/w w .Total of 268 patients with dermatophytosis at geographically distributed centres in India will be enrolled in this clinical trial to evaluate the efficacy and safety of naftifine hydrochloride cream 2% w/w as compared to terbinafine hydrochloride cream 1% w/w. The enrolled patients would be assigned to either of the 2 study groups in a double-blinded manner according to the centralized computer generated randomization in a 1:1 (test: reference) ratio.
In this study, the patients with dermatophytosis will be screened (visit 1) upto one day prior to their enrollment. The eligible patients will then be enrolled and randomized to either of the 2 study groups in a double-blinded manner during the baseline visit (visit 2, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 1 (visit 3), week 2 (visit 4) and week 4 / 2 weeks after visit 4 (visit 5). This will be a parallel group study and all the enrolled patients will be instructed to apply the study medication topically regularly for a treatment period of 2 weeks.
 
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