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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349998
• Other study ID #: MP-1005
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2011
• Last updated: January 22, 2013
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Tinea Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Tinea
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tinea Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belize,  El Salvador,  Honduras,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Adverse Events	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.	One Year	No
Secondary	Clinical Cure and Mycological Cure	Proportion of patients achieving effective treatment	1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment	No