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1 Clinical Trial Details (PDF Generation Date :- Fri, 12 Oct :41:24 GMT) CTRI Number CTRI/2009/091/ [Registered on: 10/09/2009] - Last Modified On 02/04/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randomized, Parallel Group, Active Controlled Trial A clinical trial to study the effects of two drugs, naftifine and terbinafine in patients with dermatophytosis. Evaluation of efficacy and safety of naftifine versus terbinafine in the treatment of dermatophytosis: a randomized, open label, parallel group, active controlled, multi-centre study. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) SUN/NAFTER/0309 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > Sun Pharmaceutical Industries Ltd. Type of Sponsor List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Sun Pharmaceutical Industries Ltd. of Site Site Phone/Fax/ Dr. Nitin Punyarthi Bhagat Polyclinic Ganjawala Apts. 2nd floor,ganjawala Lane, Borivali (west) Dr. Paragkumar G. Shah Dr. Vijay P. Zawar Dr. Paragkumar G. Shah?s Clinic Dr. Vijay P. Zawar?s Clinic 5, Ground Floor, Anant Appts.,Near Aradhana Cinema Vadodara 21, Shreeram Sankul,Opp. Hotel Panchavati, Vakilwadi Nashik Dr. R. R. Chougule Laxmi Hospital 223/E, Nr. Kiran Bunglow,Tarabai Park Kolhapur Dr. Rajat Bhatiya Shraddha Skin Care Clinic , 2nd floor, Dream Land Plaza,Opp. Municipal Market, Near Relax Cinema, New Civil Road Bharuch Dr. Mahesh C. Patel Skin Care Clinic Opp. Arogyanagar,Nr. Bus Stop N/A Dr. Mukesh B. Ruparelia Skin Care Hospital 2nd floor, Dhebar Road,Opp. S.T. Bus Stand, Above Shreeji Medical Rajkot m vzawar@gmail.com om oo.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr. Sunil Trivedi Trivedi Skin Care & Cosmetic Clinic 10, Shivdarshan Complex,Opp. T. V. S. Auto Point, Parvat Patia Surat drsuniltrivedi@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Mahesh C. Patel Mukesh B. Ruparelia Nitin Punyarthi Paragkumar G. Shah R. R. Chougule Rajat Bhatiya Sunil Trivedi Vijay P. Zawar Status Approved/Obtained Health Type Date No Date Specified Condition Dermatophytosis Type Details Intervention Naftifine cream 1 % Once daily for 4 weeks Comparator Agent Terbinafine cream 1 % Once daily for 4 weeks Age From Age To Gender Details Inclusion Criteria 1.Male or female patients aged between 18 and 65 years. 2.Patients with a clinical diagnosis of dermatophytosis. 3.Patient willing to give page 3 / 5

4 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Centralized their informed consent. Exclusion Criteria 1.Pregnant or lactating women and women of childbearing potential who are not on an acceptable birth control methods. 2.Patients with any systemic condition predisposing them to fungal infection or with any skin disease that might interfere with the study. 3.Patients using topical antifungals, topical corticosteroids, or systemic antibacterials before 14 days of study entry. 4.Patients using systemic antifungals or corticosteroids before 4 weeks of the study entry. 5.Patients using other concomitant systemic or topical therapy with antibiotics, antimycotics or corticosteroids. 6.Patients having hypersensitivity with Naftifine or Terbinafine. 7.Patients having a serum creatinine of > 1.5 x upper limit of normal. 8.Patients having history of alcohol, narcotic or drug abuse. 9.Patients with severe renal and hepatic impairment. 10.Patients having thyroid stimulating hormone value outside the normal range. Primary Outcome Outcome Timepoints Assessment of following symptoms using 4 point Visual Analogue Scale (VAS). 1.Percentage of patients with erythema. 2.Percentage of patients with pruritus. 3.Percentage of patients with maceration. 4.Percentage of patients with fissuring. 5.Percentage of patients with scaling. Baseline (Day 0), week 2 and week 4. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 1.Average change from baseline in Clinical Global Impression on Severity (CGI-S) in patients by investigator. 2.Clinical Global Impression on Improvement (CGI-I) in patients by investigator. Total Sample Size=0 Sample Size from = No Date Specified 15/09/2009 Years= Months=0 Days=0 Completed 1.Baseline (day 0) and week 4 2.Week 2 and week 4 This study is a randomized, open label, parallel group, active controlled, multi-centre study comparing the safety and efficacy of naftifine cream 1% and terbinafine cream 1% for 4 weeks in 200 patients with dermatophytosis that will be conducted in only. The primary outcome measures will be evaluation of percentage of patients with symptoms such as erythema, pruritus, maceration, fissuring and scaling using 4 point visual analogue scale at baseline (day 0), week 2 and week 4. The secondary outcomes will be clinical global impression on severity at baseline visit page 4 / 5

5 Powered by TCPDF ( PDF of Trial (day 0) and week 4; and clinical global impression on improvement at week 2 and week 4. The anticipated date of enrollment will be 15th September 2009, subject to registration at CTRI. This is not a global trial. page 5 / 5