Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00722189
First received: July 14, 2008
Last updated: March 18, 2015
Last verified: March 2015
History of Changes
  Purpose
An assessment of the efficacy and safety of Travogen cream and Travocort cream in the treatment of local skin mycoses

Condition
Skin Mycoses

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
Enrollment: 900
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
All patients treated

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: July 14, 2008
Last Updated: March 18, 2015
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Bayer:
Mycoses

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

ClinicalTrials.gov processed this record on September 23, 2016