An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz North America, Inc.; Merz Pharmaceuticals, LLC
• Treatments: Naftifine

Criteria

Inclusion Criteria:

• Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.

• Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.

• KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.

• Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.

Exclusion Criteria:

• Tinea infection of the scalp, face, groin, and/or feet.

• A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months

• Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.

• Subjects with a known hypersensitivity or other contradictions to study medications or their components.