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

• Status: Withdrawn
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Fulford India Limited
• Treatments: Nadifloxacin; Sisomicin

Criteria

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.