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Observational Study of Efficacy and Safety of Travogen Cream and Travocort Cream in the Treatment of Mycoses

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ClinicalTrials.gov Identifier: NCT00722189
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
An assessment of the efficacy and safety of Travogen cream and Travocort cream in the treatment of local skin mycoses

Condition or disease
Skin Mycoses

Study Design
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Study Type : Observational
Actual Enrollment : 900 participants
Time Perspective: Prospective
Official Title: Observational Study of the Efficacy, Safety and Tolerance of Travogen Cream (Isoconazole) and Travocort Cream (Isoconazole, Diflurcortolone) in the Treatment of Patients With Local Skin Mycosis of Various Etiology and Localization
Study Start Date : July 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
A
All patients treated


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of Travogen / Travocort in the treatment of skin mycoses / Travogen Cream and Travocort Cream will be prescribed by a physician [ Time Frame: Baseline to end of study ]

Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: Baseline to end of study ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosed skin mycoses
Criteria

Inclusion Criteria:

  • Diagnosis of skin mycosis

Exclusion Criteria:

  • Allergies to study medication
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722189


Locations
Russian Federation
Kashkin Clinical Research Mycological Institute
St Petersburg, Russian Federation
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here and search for websynopsis results  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00722189     History of Changes
Other Study ID Numbers: 2008/01850
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Bayer:
Mycoses

Additional relevant MeSH terms:
Mycoses
Dermatomycoses
Skin Diseases, Infectious
Infection
Skin Diseases