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

This study has been completed.

First Received: July 14, 2008 Last Updated: July 22, 2009 History of Changes

Sponsor:	Intendis GmbH
Information provided by:	Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00722189

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:	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:

MedlinePlus related topics: Fungal Infections

Drug Information available for: Isoconazole nitrate Isoconazole

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Study Population

Patients with diagnosed skin mycoses

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Keywords provided by Intendis GmbH:

Mycoses

Additional relevant MeSH terms:

Mycoses
Skin Diseases, Infectious
Skin Diseases
Infection
Dermatomycoses

ClinicalTrials.gov processed this record on February 09, 2010