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CTRI Number  CTRI/2012/09/003000 [Registered on: 17/09/2012] Trial Registered Retrospectively
Last Modified On: 15/04/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to evaluate the efficacy and safety of 3 study drugs in treatment of patients with with any type of eczematous disorder associated with underlying tinea / yeast infection  
Scientific Title of Study   A Randomized, open label, comparative, parallel group, three-arm study to evaluate the efficacy, safety and tolerability of a combination of clobetasol, neomycin and miconazole versus combination of betamethasone, clotrimazole, neomycin versus combination of betamethasone, gentamicin, miconazole in patients with any type of eczematous disorder associated with underlying tinea / yeast infection  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Lobate GM neo AHPL/05/2012,Version - 1: dated: 07/05/12   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  DrManoj Naik 
Designation  Chief Manager, Clinical Research 
Affiliation  Abbott Healthcare Pvt Ltd 
Address  D-mart building, goregaon mulund link road, Mulund (w) , Mumbai

Mumbai
MAHARASHTRA
400080
India 
Phone  022-39536910  
Fax  022-39536665  
Email  manoj.naik@abbott.in  
 
Details of Contact Person
Public Query  
Name  MrManoj Prabhu 
Designation  Manager, Clinical Research 
Affiliation  Abbott Healthcare Pvt Ltd 
Address  D-mart building, goregaon mulund link road, Mulund (w) , Mumbai

Mumbai
MAHARASHTRA
400080
India 
Phone  022-39536910  
Fax  022-39536665  
Email  manoj.prabhu@abbott.in  
 
Source of Monetary or Material Support  
Abbott Healthcare Pvt Ltd, Mumbai 
 
Primary Sponsor  
Name  Abbott Healthcare Pvt Ltd 
Address  D-Mart Building, Goregaon Mulund Link Road , Mulund (w), mUMBAI- 400080 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrHasmukh Shroff  Anand Bhavan Clinic  Department of Dermatology, B.Desai Marg, Mumbai- 400025
Mumbai
MAHARASHTRA 		 9820506431

hjshroff@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
League Health Independent Ethics Committee, Thane Maharashtra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  eczematous disorder with underlying tinea/yeast infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A combination of clobetasol, neomycin and miconazole  combination of clobetasol, neomycin and miconazole ) to be applied twice daily to the affected areas for 1 week  
Comparator Agent  Combination of betamethasone, clotrimazole, and neomycin   Combination of betamethasone, clotrimazole, and neomycin to be applied twice to the affected areas for 1 week  
Comparator Agent  Combination of betamethasone, gentamicin, and miconazole   Combination of betamethasone, gentamicin, and miconazole to be applied twice to the affected areas for 1 week  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Patients aged 18 years and above diagnosed with any type of eczematous disorder associated presenting clinical features of underlying tinea/yeast infection
•Patients who agree to adhere to the study design
•Patients who give their consent for participation in this study
 
 
ExclusionCriteria 
Details  •Pregnant or lactating females
•Indications for use of systemic therapy
•Patients sensitive to corticosteroids
•Patients who have immune deficiency, hepatic or renal impairment
•Patients who have been on any therapy within 1 month prior to enrollment in the study
•Patients who are using any other concomitant therapy
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Improvement in clinical score from baseline  Baseline, Day3, Day5 and Day7 
 
Secondary Outcome  
Outcome  TimePoints 
• Improvement in scaling and inflammation
• Improvement in burning and itching
• Adverse event assessment
• Acceptability of the treatment
• Tolerance of the treatment
• Global assessment for efficacy by Investigator and Patient
• Global assessment for tolerability by Investigator and Patient
 		 Baseline, Day3, Day5 and Day7 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/07/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   study will be published in national journal 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is done to evaluated the efficacy and safety of a combination of clobetasol, neomycin and miconazole versus combination of  betamethasone, clotrimazole, neomycin versus combination of betamethasone, gentamicin, miconazole in patients with any type of eczematous disorder associated with underlying tinea / yeast infection 
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