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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tinea Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01349998
First received: May 3, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Tinea Pedis
Tinea Cruris
Tinea Corporis
 Drug: Product 33525
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tinea Pharmaceuticals:

Primary Outcome Measures:
  • Number of Subjects with Adverse Events [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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:
  • Clinical Cure and Mycological Cure [ Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment ] [ Designated as safety issue: No ]
    Proportion of patients achieving effective treatment


Enrollment: 604
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349998

  Show 24 Study Locations
Sponsors and Collaborators
Tinea Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tinea Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01349998     History of Changes
Other Study ID Numbers: MP-1005
Study First Received: May 3, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013