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.
- Conditions
- Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissueHealth Condition 2: null- Patients with infected skin lesions by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA) and/or S. Pyogenes.
- Registration Number
- CTRI/2017/07/009091
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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 Wrightâ??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.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of adverse events for test treatment between three study groups.Timepoint: On Day 7 & and Day 14.
- Secondary Outcome Measures
Name Time Method Reduction in Colony Forming Units from baselineTimepoint: On Day 03, 05 and 07.