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CompletedNCT01349998Updated Jan 23, 2013

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

A Phase 3 interventional study of Product 33525 in Tinea Pedis, Tinea Cruris and Tinea Corporis, sponsored by Tinea Pharmaceuticals. Completed at 24 sites in 5 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2013-01-23.

Sponsored by Tinea Pharmaceuticals · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
604
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tinea Pedis
  • Tinea Cruris
  • Tinea Corporis

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03

In context

Tinea Pedis

73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.

This study's enrollment of 604 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.

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Lead sponsor

Tinea Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy and allergies. Additional criteria listed in protocol
05

Study design

Phase
Phase 3
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
604 participants (actual)

Study arms

  • Experimental
    Safety Population

    Drug: Product 33525

Interventions

  • DrugProduct 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One Year

Secondary outcomes

  1. Clinical Cure and Mycological Cure

    Proportion of patients achieving effective treatment

    Time frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment

07

Study locations

24 sites
  • Fremont, California, United States
  • Los Angeles, California, United States
  • Miami, Florida, United States
  • Miramar, Florida, United States
  • St. Petersburg, Florida, United States
  • Augusta, Georgia, United States
  • Evansville, Indiana, United States
  • Warren, Michigan, United States
  • Omaha, Nebraska, United States
  • Paramus, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Cincinatti, Ohio, United States
  • Hershey, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Goodletsville, Tennessee, United States
  • Austin, Texas, United States
  • College Station, Texas, United States
  • Plano, Texas, United States
  • San Antonio, Texas, United States
  • Lynchburg, Virginia, United States
  • Belize City, Belize
  • San Salvador, El Salvador
  • San Pedro, Sula, Honduras
  • Cidra, Puerto Rico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01349998
Lead sponsor
Tinea Pharmaceuticals
Responsible party
Sponsor
First posted
May 9, 2011
Start date
May 2011
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Jan 23, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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