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.

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. - CRSC16001

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/07/009091

Enrollment

Registered

2017-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue Health Condition 2: null- Patients with infected skin lesions by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA) and/or S. Pyogenes.

Interventions

Intervention1: 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. Control Intervention1: Not Applicable:

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Comparison of adverse events for test treatment between three study groups.Timepoint: On Day 7 & and Day 14.	—

Secondary

Measure	Time frame
Reduction in Colony Forming Units from baselineTimepoint: On Day 03, 05 and 07.	—

Countries

India

Contacts

Public ContactDr Purav Thakkar

Cadila Pharmaceuticals Limited

pramit.sonone@cadilapharma.co.in9763056258

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026