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CTRI Number  CTRI/2019/04/018858 [Registered on: 30/04/2019] Trial Registered Prospectively
Last Modified On: 15/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [treatment of secondarily infected traumatic skin lesions ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Randomized, double-blind, placebo-controlled, three-arm parallel design, multiple-site bioequivalence study with clinical endpoints 
Scientific Title of Study   A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Mupirocin Cream USP 2% (Encube Ethicals Private Limited, India) to Mupirocin Cream USP 2% (Glenmark Pharmaceuticals Inc., USA) in the Treatment of Subjects with Secondarily Infected Traumatic Skin Lesions. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
G7SYN/P-002/2018,VERSION NO-01,Dated 15 Sep 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Alexander 
Designation  Medical Monitor 
Affiliation  G7 Synergon Private Limited 
Address  No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India

Bangalore
KARNATAKA
560092
India 
Phone  9916252529  
Fax    
Email  ajay.alexander@g7synergon.in  
 
Details of Contact Person
Scientific Query  
Name  Dr D Sathish Kumar 
Designation  Managing Director 
Affiliation  G7 Synergon Private Limited 
Address  No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India

Bangalore
KARNATAKA
560092
India 
Phone  9677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr D Sathish Kumar 
Designation  Managing Director 
Affiliation  G7 Synergon Private Limited 
Address  No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India

Bangalore
KARNATAKA
560092
India 
Phone  9677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Source of Monetary or Material Support  
Encube Ethicals Private Limited Encube Ethicals Private Limited Unit No 24 Steelmade Industrial Estate Marol Village Andheri (E) Mumbai 400 059 India  
 
Primary Sponsor  
Name  Encube Ethicals Private Limited 
Address  Unit No 24 Steelmade Industrial Estate Marol Village Andheri (E) Mumbai 400 059 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 = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shatrughan Sahay  Ajanta Hospital and IVF Centre  765 ABC Complex Kanpur Road Alambagh Lucknow 226005
Lucknow
UTTAR PRADESH 		 9721936101

drshatru@yahoo.com 
Dr Sharmila Patil  DR D Y Patil Hospital and Research centre  Clinical research centre Sec 5 Nerul Navi Mumbai 400706 Maharastra India
Mumbai
MAHARASHTRA 		 9821350217

drsharmilapatil@gmail.com 
Dr Krina Bharat Patel  GMERS Medical College and Civil Hospital  Clinical research department Near Gujarat High Court S.G Highway Sola Ahmedabad 380060 Gujarat India
Ahmadabad
GUJARAT 		 9227222221

y2k_kbpatel@yahoo.com 
Dr Hemant R Gupta  Grant Government Medical College And SIR J J Group of Hospitals  Clinical research department Byculla Mumbai 400008 India
Mumbai
MAHARASHTRA 		 9820095763

drhemantgupta@hotmail.com 
Dr Jayesh Shah  HI Tech Multi specialty hospitL  Clinical research Department Sector 3 D Plot No 1180 Gh Road Near Gh 11 2 Bus Stand Gandhinagar Gujarat 382003 India
Gandhinagar
GUJARAT 		 9824026108

hitechhospital.cr@gmail.com 
Dr Suresh Harbade   Ishwar Institute of Health Care   Ishwar Heights, Plot no7,Gut no.6/1, Beside Punjabi bhawan, Padegaon, Mumbai-Nashik Highway,Aurangabad-431002, Maharashtra, India.
Aurangabad
MAHARASHTRA 		 9890069313

drsharbade@gmail.com 
Dr Jitendra Anand  Kanoria Hospital and Research centre  Dermatology Department,Airport Gandhinagar Highway Village Bhat Gandhinagar 382428 Gujarat India
Gandhinagar
GUJARAT 		 9824517101

jkanand09@gmail.com 
Dr Vipul Gupta  KRM Hospital and Research Centre  Clinical research department 3 92 93 Vijayant khand Gomtinagar Lucknow 226010 Uttar Pradesh India
Lucknow
UTTAR PRADESH 		 9005044010

krmhrclko@gmail.com 
Dr Sonal Mahadev Shendkar  Lifepoint Multi specialty Hospital  Clinical research department 145 1 Mumbai Bangalore Highway Near Hotel Sayaji Wakad Pune 411057 Maharashtra India
Pune
MAHARASHTRA 		 9960178611

Shendkar.sonal82@gmail.com 
Dr Micky Patel  Lotus Multispeciality Hospital  Room No 02 2nd Floor Beside Swastik School Motera Stadium Road Motera Ahmedabad 380005 Gujarat India
Ahmadabad
GUJARAT 		 9909007305

crc.lotus@gmail.com 
Dr Arpita Agarwal  M V Hospital and Research centre  Deramatology Department 314 30 Mirza Mandi Chowk Lucknow 226003 Uttar Pradesh India
Lucknow
UTTAR PRADESH 		 9456658989

arpita.11june@gmail.com 
Dr Grandhi Sudhakarrao Venkata  Medipoint Hospital Pvt Ltd  Clinical Research Department 241 1 New D P Road Near Sai Heritage Aundh Pune 411007 Maharashtra India
Pune
MAHARASHTRA 		 9960666158

sudhakargrandhi.pentagon@gmail.com 
Dr Nishith Gandhi  Medistar Multispeciality Hospital  Clinical research department Trimurti Avenue Medistar Cross Road National Highway 8 Industrial Area Himatnagar 383001 Gujarat India
Ahmadabad
GUJARAT 		 9825618968

drnishithgandhi@yahoo.co.in 
Dr Ruchir Shah  Sanjivani Super Specialty hospital  Clinical research department 1 New Uday Park Society Near Sunrise Park Vastrapur Ahmedabad 380015 Gujarat India
Ahmadabad
GUJARAT 		 9904079691

drruchirshah.dermatologist@gmail.com 
Dr Smita A Nagpal  Saviour Multi specialty Hospital  Clinical research department Near Bharat Petrol Pump Near lakhudi Talav Stadium Road Navrangpura Ahmedabad 380014 Gujarat India
Ahmadabad
GUJARAT 		 9825721525

nagpalsmita@gmail.com 
Dr Hamsraj Alva  Vinaya Hospital and Research centre  Clinical research department PO BOX 717 Karangalpady Mangalore 575003 Karnataka India
Dakshina Kannada
KARNATAKA 		 9343562622

hansalva2001@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Ethics Committee Vinaya Hospital  Submittted/Under Review 
Hi-Tech Ethics Committee  Approved 
Institutional Ethics Committee Dr. D Y Patil Medical College  Approved 
Institutional Ethics Committee For Ajanta Hospital   Submittted/Under Review 
Institutional Ethics Committee Grant Government Medical College   Approved 
Institutional Ethics Committee M V Hospital and Research Centre  Submittted/Under Review 
Institutional Ethics Committee of GMERS Medical Collage  Submittted/Under Review 
Ishwar Hospital Ethics committe  Approved 
Kanoria Ethics Committee  Approved 
KRM Hospital Ethics Committee  Approved 
Lotus Ethics Committee  Approved 
LPR Ethics Committee  Approved 
Medistar Hospital Ethics Committee  Approved 
Penta-Med Ethics Committee, Medipoint Hospital Pvt. Ltd  Approved 
Sanjivani Hospital Ethics Committee  Approved 
Saviour Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human subjects with Secondarily Infected Traumatic Skin Lesions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cream vehicle of test product  Apply topically a thin layer of cream to the affected area with a piece of clean cotton swab or gauze pad 3 times daily for 10 consecutive days 
Comparator Agent  Mupirocin Cream USP 2%  Apply topically a thin layer of cream to the affected area with a piece of clean cotton swab or gauze pad 3 times daily for 10 consecutive days 
Intervention  Mupirocin Cream USP 2%   Apply topically a thin layer of cream to the affected area with a piece of clean cotton swab or gauze pad 3 times daily for 10 consecutive days 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)Healthy male and non-pregnant female subjects 18 months of age or older with a definite clinical diagnosis of a secondarily infected traumatic skin lesion such as a laceration, sutured wound or abrasion (The laceration or sutured wound should not exceed 10 cm in length with surrounding erythema not more than 2 cm from the edge of the lesion or abrasion should not exceed 100 cm2 in area with surrounding erythema not more than 2 cm from the edge of the abrasion).
2)Positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
3)Subjects with a Skin Infection Rating Scale (SIRS) total score of at least 8 at baseline and have white blood cells observed on Wright stain or Gram stain slide prepared from wound pus/exudates.
4)Female Subjects of child bearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-barrier method, transdermal, injection or implants, non-hormonal or hormonal, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment. OR
Postmenopausal for at least 1 year. OR
Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
Note: Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to the study.
5)Male subjects must use accepted methods of birth control including abstinence
6)Subject willing to provide written consent or assent, as appropriate.
7)Subjects shall be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
8)Subjects shall be in good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesions, that might interfere with the study evaluations.
9)Willing to refrain from the use of all other topical medications or antibiotics during the 10-day treatment period. 
 
ExclusionCriteria 
Details  1)Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
2)Subject with positive urine pregnancy test at screening.
3)Subjects with primary or secondary immunodeficiency.
4)Subjects with systemic signs or symptoms of infection. (i.e., fever defined as an oral temperature greater than 101ºF or 38.3ºC).
5)Subjects with Diabetes.
6)Any dermatological disorder that may interfere with the evaluation of the subject’s secondarily infected traumatic skin lesion(s), e.g., acute or chronic dermatitis involving affected area.
7)Subjects who require surgical intervention for treatment of infection.
8)Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
9)Subjects who have a known hypersensitivity to any of the following (in any dosage form): penicillin’s, cephalosporin’s, other beta-lactam antimicrobials or mupirocin and/or to any component of the study medications.
10)Subjects with a bacterial skin infection that, because of depth or severity, should not be treated with a topical antibiotic (e.g., severe cellulitis, abscess, ulcer, furunculosis).
11)Subjects who have a secondarily infected bite (animal, human or insect) or puncture wound. Note: Infections resulting from the scratching of an insect bite shall be considered secondarily infected traumatic skin lesions.
12)Subjects who have applied any topical therapeutic agent i.e. topical corticosteroid, topical antibiotic, or antifungal directly to the wound within 48 hours prior to study entry.
13)Subjects who have been treated with a systemic antibiotic or systemic corticosteroid within 7 days prior to study entry.
14)Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with this protocol.
15)Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
16)Subjects who have been previously enrolled in this study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.SIRS – Skin Infection Rating Scale
2.Bacteriologic Culture 		 Visit 1, 2, 3 and 4 
 
Secondary Outcome  
Outcome  TimePoints 
Monitoring Adverse events  Visit 1, 2, 3 and 4 
 
Target Sample Size   Total Sample Size="696"
Sample Size from India="696" 
Final Enrollment numbers achieved (Total)= "696"
Final Enrollment numbers achieved (India)="696" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   08/05/2019 
Date of Study Completion (India) 04/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/02/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Mupirocin Cream USP 2%  in the Treatment of 696 Subjects with Secondarily Infected Traumatic Skin Lesions. At screening/baseline visit, subjects shall be randomly (Double’blind) assigned in 1:1:1 fashion to one of the 3 treatment groups at visit 1. A specimen for bacterial culture shall be prepared from wound pus/exudates as well as a slide shall be prepared for Wright stain/Gram stain during screening/baseline visit. A specimen for bacterial culture shall be prepared from wound pus/exudates at Visit 3 and Visit 4. Statistical comparisons shall be made between test and reference, test and placebo, and reference and placebo. The primary endpoint is the clinical response, Bacteriological response as determined at visit 4/follow-up. 
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