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Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01349998
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.

Condition or disease Intervention/treatment Phase
Tinea Pedis Tinea Cruris Tinea Corporis Drug: Product 33525 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris
Study Start Date : May 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Safety Population Drug: Product 33525
Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects with Adverse Events [ Time Frame: One Year ]
    To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted.


Secondary Outcome Measures :
  1. Clinical Cure and Mycological Cure [ Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment ]
    Proportion of patients achieving effective treatment


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol

Exclusion Criteria:

  • Pregnancy and allergies. Additional criteria listed in protocol
Contacts and Locations

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): NCT01349998


  Show 24 Study Locations
Sponsors and Collaborators
Tinea Pharmaceuticals
More Information

Responsible Party: Tinea Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01349998     History of Changes
Other Study ID Numbers: MP-1005
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms