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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01349998
• Date of registration: 03/05/2011
• Prospective Registration: No
• Primary sponsor: Tinea Pharmaceuticals
• Public title: Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
• Scientific 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
• Date of first enrolment: May 2011
• Target sample size: 604
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01349998
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 3

Countries of recruitment

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

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Tinea Cruris

Tinea Pedis

Tinea Corporis

Intervention(s)

Drug: Product 33525

Primary Outcome(s)

Number of Subjects with Adverse Events [Time Frame: One Year]

Secondary Outcome(s)

Clinical Cure and Mycological Cure [Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment]

Secondary ID(s)

MP-1005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors