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:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00722189
First received: July 14, 2008
Last updated: July 22, 2009
Last verified: July 2009
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 Intendis GmbH:

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 ]

Estimated 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

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
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
Intendis GmbH
Investigators
Principal Investigator: Lubov Kotrekhova, MD Kashkin Clinical Research Mycological Institute
  More Information

No publications provided

Responsible Party: Sergey Esenin, Intendis Russia
ClinicalTrials.gov Identifier: NCT00722189     History of Changes
Other Study ID Numbers: 2008/01850
Study First Received: July 14, 2008
Last Updated: July 22, 2009
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Intendis GmbH:
Mycoses

Additional relevant MeSH terms:
Dermatomycoses
Mycoses
Skin Diseases, Infectious
Infection
Skin Diseases
 Isoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013