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CTRI Number  CTRI/2011/11/002179 [Registered on: 30/11/2011] Trial Registered Retrospectively
Last Modified On: 17/08/2012
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 1% Pimecrolimus topical cream versus 1% Elidel topical cream in a multiple hospitals randomly distributed Atopic Dermatitis patients in India 
Scientific Title of Study   A Randomized, Controlled, Open Label, Multicentre, Parallel-Group, Comparing Safety and Efficacy of Pimecrolimus 1% Topical Cream (Biocon’s Formulation) Versus Elidel® 1% Topical Cream (Novartis) in Patients with Atopic Dermatitis. 
Trial Acronym  Race 
Secondary IDs if Any  
Secondary ID  Identifier 
G7SYN/P-007/2011  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 Limited 20th km Hosur Road
Electronics City
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 Limited 20th km Hosur Road
Electronics City

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 Limited 20th km Hosur Road
Electronics City

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   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravindra Mohan AL  Government General Hospital  4th T Block, Jayanagar South, Bangalore - 560041
Bangalore
KARNATAKA 		 09482012015

ravimohan2403@yahoo.com 
Dr Manjunath JV  Naik Skin Clinic  1479 1st Floor D.R.L.S Plaza Above Andhra Bank Tumkur Road T. Dasarahalli Bangalore 560057
Bangalore
KARNATAKA 		 09844314117

naikskinclinic@gmail.com 
Dr Aruna Prasad  Pranav Diabetes Center  Pranav Diabetes Center No 53 Nanda Complex Ramamurthy Nagar Main Road Banasawadi Bangalore 560043
Bangalore
KARNATAKA 		 09341231511
08040943801
arunapras@gmail.com 
Dr Nazima Ruby  Radiant Skin Clinic  Radiant Skin Clinic No 75 M S Plaza Wheelers Road Cox Town Bangalore 560005
Bangalore
KARNATAKA 		 09845198062

rubynazima@yahoo.in 
Dr Nagaraja  Sujana Skin and Cosmetic Clinic  Sujana Skin and Cosmetic Clinic No 197/x BSK 3rd Stage East Katriguppa 4th Phase Near Chennammanakere Acchukattu Telephone Exchange Bangalore 560085
Bangalore
KARNATAKA 		 09980950103

prof_nagaraja@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
ACE Ethics (Site I - Dr. Aruna Prasad)  Approved 
ACE Ethics (Site II - Dr. Nazima Ruby)  Approved 
ACE Ethics (Site III - Dr. Nagaraja)  Approved 
ACE Ethics (Site IV - Dr. Ravindra Mohan A.L  Approved 
ACE Ethics (Site V - Dr. Manjunath J.V)  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  ELIDEL® 1% (Pimecrolimus Cream 1%)  Daily two time topical application separated by about 12 hours in the morning and night for 21 days 
Intervention  Pimecrolimus Cream 1% w/w  Daily two time topical application separated by about 12 hours in the morning and night for 21 days 
 
Inclusion Criteria  
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 Rajika diagnostic standards
•Patient 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 2 (mild) to 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 naïve patients and/or patients receiving treatments for atopic dermatitis other than pimecrolimus 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 pimecrolimus or any excipient of the cream
•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 histamines least 7 days prior to the first dosing day or throughout the study.
•Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of immunosuppressants, 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 randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage change in Investigators Global Assessment (IGA) from baseline with Pimecrolimus 1% topical cream (Biocon’s formulation) versus Elidel® 1% topical cream (Novartis) in patients with Atopic Dermatitis after 21 days of treatment  21 days of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Percentage change in Eczema Area and Severity Index (EASI) from baseline with Pimecrolimus 1% topical cream versus Elidel® 1% topical cream (Novartis) in patients 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 from baseline with Pimecrolimus 1% topical cream versus Elidel® 1% topical cream (Novartis) in patients 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 Pimecrolimus 1% topical cream versus Elidel® 1% topical cream (Novartis) in patients with Atopic Dermatitis after 21 days of treatment
 		 21 days of treatment  
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 08/12/2011 
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="3"
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 multicentric, randomized, controlled, open label, parallel-group, 2 arm study which is intended to evaluate the safety and efficacy of Pimecrolimus  cream 1%  w/w (Biocon’s Formulation) in comparison with Elidel® cream 1% (Novartis) in patients (adults and children) with Atopic Dermatitis after 21days of treatment. Patients meeting the eligibility criteria will be randomized in 1:1 ratio to the treatment arms. Patients will receive topical application of either Pimecrolimus cream 1% w/w (Biocon’s Formulation) or Elidel® cream 1% (Novartis) for a duration of 21 days and will be followed up for another 7 days. The study will recruit 246 patients only from India. This study is sponsored by Biocon Limited with five study centers across India.

 
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