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CTRI Number  CTRI/2011/12/002237 [Registered on: 15/12/2011] Trial Registered Prospectively
Last Modified On: 07/06/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study on Treatment of Tacrolimus (0.03% and 0.1%) Topical Ointment Versus Protopic(0.03% and 0.1%)Topical Ointment in multiple hospitals randomly distributed Atopic Dermatitis in Children and Adults patient population in India 
Scientific Title of Study
Modification(s)  		 A Randomized, Open Label, Multicentre, Parallel-Group, Four Arm, Study Comparing Safety and Efficacy of Tacrolimus Topical Ointment (Biocon’s Formulation) Versus Protopic® Topical Ointment (Astellas Pharma) in Children and Adults with Atopic Dermatitis 
Trial Acronym  Race 
Secondary IDs if Any  
Secondary ID  Identifier 
B/CT/11/002  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vanita Sabhahit 
Designation  Manager Medical Affairs and Clinical Operation 
Affiliation  Biocon Limited 
Address  Biocon Ltd 20th km Hosur Road
Electronics City PO
Bangalore
KARNATAKA
560100
India 
Phone  08028087513  
Fax  08028082080  
Email  vanita.sabhahit@biocon.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vanita Sabhahit 
Designation  Manager Medical Affairs and Clinical Operation 
Affiliation  Biocon Limited 
Address  Biocon Ltd 20th km Hosur Road
Electronics City PO
Bangalore
KARNATAKA
560100
India 
Phone  08028087513  
Fax  08028082080  
Email  vanita.sabhahit@biocon.com  
 
Details of Contact Person
Public Query  
Name  Dr Vanita Sabhahit 
Designation  Manager Medical Affairs and Clinical Operation 
Affiliation  Biocon Limited 
Address  Biocon Ltd 20th km Hosur Road
Electronics City PO
Bangalore
KARNATAKA
560100
India 
Phone  08028087513  
Fax  08028082080  
Email  vanita.sabhahit@biocon.com  
 
Source of Monetary or Material Support  
Biocon Limited 
 
Primary Sponsor  
Name  Biocon Limited 
Address  Biocon Limited 20th km Hosur Road Electronics City Bangalore 560100 Karnataka India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Bhat  Father Muller Medical College and Hospital  Department of Dermatology Father Muller Medical College and Hospital Kankanady Mangalore 575 002 Karnataka India
Udupi
KARNATAKA 		 09845084224

rameshderma@gmail.com 
Dr Manjunath J V  Naik Skin Clinic,  Naik Skin Clinic 1479 1st Floor, D.R.L.S Plaza Above Andhra Bank TumkurRoad T. Dasarahalli Bangalore – 560057 Karnataka India
Bangalore
KARNATAKA 		 09844314117

naikskinclinic@gmail.com 
Dr Satish KM  Prasad Skin, Hair and cosmetology Clinic  No. 22, Above Dominos Pizza, 5th Cross, Malleswaram, Bangalore-560003.
Bangalore
KARNATAKA 		 09480709014

satish.kainthaje@yahoo.co.in 
Dr Nazima Ruby  Radiant Skin Clinic  Radiant Skin Clinic No: 75 M.S. Plaza Wheelers Road Cox Town, Bangalore‐5 Karnataka India.
Bangalore
KARNATAKA 		 09845198062

rubynazima@yahoo.in 
Dr D N Balaraj  Rajbal Skin Clinic  Rajbal Skin Clinic no 401 Ratanmahal Shreyas 7th C Main 4th B Cross 1st Block HRBR Layout Kalyan Nagar Bangalore 560 043
Bangalore
KARNATAKA 		 09845402950

dnbalraj@rediffmail.com 
Dr Sheela Shivamohan  S P Clinic  S P Clinic # 304 9th Cross HMT Layout R T Nagar Bangalore 560032 Karnataka Inida
Bangalore
KARNATAKA 		 09844050920

drsheelananda@gmail.com 
Dr Manjunath Shenoy  Vish Skin Clinic  VISH Skin Clinic 1st floor Opposite Hotel Swagath Balmatta Mangalore 575 002 Karnataka India
Udupi
KARNATAKA 		 09845009976

manjunath576117@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
ACE ETHICS (Site I – Dr. Manjunath Shenoy)   Approved 
ACE ETHICS (Site II -Dr. D N Balaraj)  Approved 
Father Muller Institutional Ethics Committee (Site III – Dr. Ramesh Bhat)  Approved 
INDEPENDENT ETHICS COMMITTEE -ADITYA (Site IV - Dr.Nazima Ruby S)  Approved 
INDEPENDENT ETHICS COMMITTEE -ADITYA (Site V - Dr.Manjunath JV)  Approved 
INDEPENDENT ETHICS COMMITTEE -ADITYA (Site VI - Dr.Sheela Shivamohan)  Approved 
Independent Ethics committee-Aditya( Site-VII-Dr. Satish KM)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Atopic Dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Protopic® (Tacrolimus 0.03% and 0.1% Ointment)   Daily two time topical application separated by about 12 hours in the morning and night for 21 days  
Intervention  Tacrolimus 0.03% and 0.1% Ointment   Daily two time topical application separated by about 12 hours in the morning and night for 21 days  
 
Inclusion Criteria
Modification(s)  
Age From  2.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  •Male or female patients aged between 2 -75 years
•Patients diagnosed with atopic dermatitis as per Hanifin and Rajka diagnostic standards
•Patient/parents/guardian is capable of understanding the purposes and risks of the trial and has given written Informed Consent
•Patient has documented evidence that they have been unresponsive to alternative traditional therapies such as topical corticosteroids, or in the investigators opinion, such first line therapy would be deemed inadvisable because of potential risks to the patient.
•Patients with an IGA score of 3 (moderate) or 4 (severe) at the time of screening
•Patients with Eczema Area and Severity Index (EASI) score of at least 15 at the time of screening
•Treatment naive patients and/or patients receiving treatments for atopic dermatitis other than tacrolimus can be included in the study after 3 days of wash out period
•Female patients of child bearing potential, using double barrier method or use a reliable method of contraception during the study
 
 
ExclusionCriteria 
Details  •Patient has clinically infected atopic dermatitis at baseline
•Patient with known hypersensitivity to macrolides in general, to tacrolimus or any excipients of the ointment
•Any dermatological condition other than atopic dermatitis that in the Investigators opinion may interfere with the evaluation of the patients atopic dermatitis
•Patients using non-sedating anti-histamines 7 days prior to the first dosing day or at any point during the study
•Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressant’s, including but not limited to human immunodeficiency virus (HIV) and cancer.
•Females who are pregnant, lactating or likely to become pregnant during the study
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Percentage change in Investigators Global Assessment (IGA) scale from baseline with Tacrolimus 0.03% and 0.1% ointment (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment  21 days of treatment 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Percentage change in Eczema Area and Severity Index (EASI) score from baseline with Tacrolimus ointment 0.03% and 0.1% (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment  21 days of treatment 
Percentage of patients showing greater than or equal to 60% improvement in IGA scale from baseline with Tacrolimus 0.03% and 0.1% ointment (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment  21 days of treatment 
Percentage of patients showing greater than or equal to 60% improvement in EASI scale from baseline with Tacrolimus 0.03% and 0.1% ointment (Biocon’s formulation) versus Protopic® 0.03% and 0.1% ointment (Astellas Pharma) in children and adults with atopic dermatitis after 21 days of treatment  21 days of treatment 
 
Target Sample Size   Total Sample Size="378"
Sample Size from India="378" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 19/12/2011 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 The study will be a multicenter, randomized, open label, parallel-group, 4 arm study which is intended to evaluate the safety and efficacy of Tacrolimus 0.03% and 0.1% ointment (Biocon’s formulation) in comparison with Protopic® 0.03% and 0.1% ointment (Astellas Pharma ) in patients (children and adults) with atopic dermatitis after 21 days of treatment. Patients meeting the eligibility criteria will be randomized in 1:1:1:1 ratio to the treatment arms. Patient (children and adults) will receive topical application of either Tacrolimus 0.03% for children or 0.1% ointment for adults (Biocon’s formulation) or Protopic® 0.03% for children and 0.1% ointment for adults (Astellas Pharma) for a duration of 21 days and will be followed up for another 7 days. The study will recruit 378 patients only from India. This study is sponsored by Biocon Limited with Six study centers across India. 
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