Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460)
June 2, 2015 updated by: Merck Sharp & Dohme LLC
Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas
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.
Study Overview
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion
December 7, 2022
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
September 16, 2005
First Submitted That Met QC Criteria
September 16, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 2, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P04460
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.