NCT00202891

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

First QC Date

September 16, 2005

Last Update Submit

June 2, 2015

Conditions

Pyoderma

Keywords

pyodermasisomicinnadifloxacin

Interventions

sisomicinDRUG

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pyoderma

Interventions

Sisomicin

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GentamicinsAminoglycosidesGlycosidesCarbohydrates
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

May 1, 2007

Study Completion

September 1, 2007

Last Updated

June 3, 2015

Record last verified: 2015-06