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

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.

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatitis Dermatomycoses Foot Dermatoses Foot Diseases Infections Intertrigo Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea Tinea Corporis Tinea Cruris

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Belize City, Belize District, Belize

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Product 33525

Drug

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

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Tinea Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: May 9, 2011
Registry last updated: Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed