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

June 8, 2023 updated by: LEO Pharma

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

An assessment of the efficacy and safety of Travogen cream and Travocort cream in the treatment of local skin mycoses

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • St Petersburg, Russian Federation
        • Kashkin Clinical Research Mycological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosed skin mycoses

Description

Inclusion Criteria:

  • Diagnosis of skin mycosis

Exclusion Criteria:

  • Allergies to study medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
A
All patients treated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: Baseline to end of study
Baseline to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Collaborators

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimated)

July 25, 2008

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/01850

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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