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Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas - Article


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Penciclovir Cream

Denavir



Clinical Trial: Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas

This study is not yet open for patient recruitment.
Verified by Schering-Plough September 2005

Sponsors and Collaborators: Schering-Plough
Fulford India Limited
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00202891

Purpose

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.
Condition Intervention Phase
Pyoderma
 Drug: sisomicin
Phase IV

MedlinePlus related topics:  Skin Conditions

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  210

Study start: October 2005

Eligibility

Ages Eligible for Study:  6 Years and above,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00202891


Study chairs or principal investigators

Ragunandan Torsekar, MD, FCPS,  Principal Investigator,  Rajiv Gandhi Medical College   

More Information

Study ID Numbers:  P04460
Last Updated:  September 19, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00202891
Health Authority: India: India''''s Drug Controller General, a division of the Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-20

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November 18, 2008



Page Updated: June 1, 2005
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