Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460)

Phase 4

Withdrawn

• Conditions: Pyoderma

• Registration Number: NCT00202891
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This open-label, randomized, parallel-group clinical study is designed to compare the efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical antibiotic cream, nadifloxacin cream, in the treatment of Indian patients with primary pyodermas.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Study Start: 2007-05
• Study Completion: 2007-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings.
• >=6 years of age.
• Written informed consent.

Exclusion Criteria

• Patients must not take any other antibiotics.
• Patients should not be hypersensitive to any of the test drugs.
• Patients are not to have any other investigational drug within one month of starting this study.
• Patients cannot be enrolled more than once in the study.
• Patients must not have any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment.
• Pregnant women and nursing mothers are to be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL