| CTRI Number |
CTRI/2017/07/009091 [Registered on: 21/07/2017] Trial Registered Prospectively |
| Last Modified On: |
10/04/2021 |
| 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 to evaluate the efficacy and safety for Fixed Dose Combination of Mupirocin calcium, Neomycin Sulfate and HT61 HCL cream in patients with infected skin lesions. |
|
Scientific Title of Study
|
A Prospective, Randomized, Parallel group Study to Evaluate the Safety and Efficacy of FDC of Mupirocin calcium, Neomycin Sulfate & HT61 HCL in Patients with infected skin lesions by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA) and or S. Pyogenes. |
| Trial Acronym |
CRSC16001 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRSC16001 Version 2.0 Dated 21 November 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Purav Thakkar |
| Designation |
General Manager-CRO |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka,
Ahmedabad – 387810, Gujarat, India.
Ahmadabad
Ahmadabad
GUJARAT
387810
India |
| Phone |
7573032107 |
| Fax |
|
| Email |
Purav.thakkar@cadilapharma.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramit Sonone |
| Designation |
Medical Monitor |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka,
Ahmedabad – 387810, Gujarat, India.
Ahmadabad
GUJARAT
387810
India |
| Phone |
9763056258 |
| Fax |
|
| Email |
pramit.sonone@cadilapharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purav Thakkar |
| Designation |
General Manager-CRO |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka,
Ahmedabad – 387810, Gujarat, India.
Ahmadabad
Ahmadabad
GUJARAT
387810
India |
| Phone |
|
| Fax |
|
| Email |
Purav.thakkar@cadilapharma.co.in |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceuticals Ltd
1389, Trasad Road, Dholka – 382225 Dist. Ahmedabad (Gujarat – India)
|
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals Limited |
| Address |
Cadila Pharmaceuticals Limited, Corporate Campus, Sarkhej-Dholka Road, Village: Bhat, Ahmedabad – 382210, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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 Madhu Shah |
Bodyline Hospital Pvt Ltd. |
Opp. Annapurna Hall, Near DEV status, New Vikas Gruh Road, Paldi.
Ahmedabad. Gujarat – 380007.
Ahmadabad
GUJARAT |
9824076703
drmshah61@gmail.com |
| Dr Sharmila Patil |
Dr. D.Y Patil Hospital |
OPD-54, 1st floor, Dr. D.Y.Patil Hospital, Nerul, Sec-5, Navi Mumbai.
Maharashtra.
Mumbai
MAHARASHTRA |
9821350217
drsharmilapatil@gmail.com |
| Dr Saurabh Kapadia |
Kanoria Hospital & Research Centre |
Airport - Gandhinagar Highway, Village - Bhat, Dist- Gandhinagar,
Gujarat – 382428.
Ahmadabad
GUJARAT |
9824261031
drsaurabhkapadia@yahoo.com |
| Dr Sonal Shendkar |
Lifepoint Multispecialty Hospital |
Lifepoint Multispecialty Hospital, 145/1 Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune – 411057, Maharashtra India
Pune
MAHARASHTRA |
9960178611
02066434300
sendkar.sonal82@gmail.com |
| Dr Shri Niwash Yadav |
Surya Super Speciality Hospital G.V. Meditech Private Limited |
Surya Super Speciality Hospital A unit of G.V. Meditech Private Limited B36/48 H Raman Niwas, Mahmoorganj Varanasi – 221010 U.P. India
Varanasi
UTTAR PRADESH |
5422315355
5422220365
dermahealth2015@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Bodyline Hospitals Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Kanoria Ethics Committee |
Approved |
| LIFEPOINT RESEARCH-ETHICS COMMITTEE |
Approved |
| The Institutional Ethics Committee G. V. Meditech Limited |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, Patients with infected skin lesions by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA) and/or S. Pyogenes., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Mupirocin 1%, Neomycin 0.5%, HT61 HCL 0.75% cream |
Cream to be applied topically on the infected skin lesion three times daily for 7 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male or non-pregnant females aged greater or equal to 18 years with an infected skin lesion including laceration, sutured wound, or abrasion.
2. The laceration or sutured wound should be between 1-10 cm in length and not requiring systemic antibiotic treatment as per PI discretion.
3. Gram stains for presence of bacteria and Wright’s stain for confirmation of white blood cells in the pus/exudate from the infected skin lesion.
4. Positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the infected skin lesion.
5. Skin Infection Rating Scale (SIRS) total score for the infected skin lesion of at least 8 at baseline.
6. Patients must be willing to provide written informed consent.
7. Patients must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed and be able to complete the study.
8. Patients must be in good health and free from any clinically significant disease, other than infected skin lesions, that might interfere with the study evaluations.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of adverse events for test treatment between three study groups. |
On Day 7 & and Day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Colony Forming Units from baseline |
On Day 03, 05 and 07. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/07/2017 |
| Date of Study Completion (India) |
13/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Prospective, Randomized, Parallel group, clinical study is designed to evaluate safety and efficacy of test cream in 30 eligible patients with infected skin lesions by Staphylococcus aureus including MRSA and/or S. Pyogenes. The cream will be applied for 3 times daily for 7 days and study will be conducted in three centers in India. The objective of this study is to compare safety profile of test cream between three study groups. Clinical and bacteriological cure rate of test cream will also be compared between the three study groups. |