An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

Completed · Phase 4

Conditions studied: Tinea Corporis

In brief

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

Key facts

Study ID

NCT02466867

Run by

Merz North America, Inc.

People needed

27

Starts

2014-01-01

Expected to finish

2015-12-01

Last updated by the study team

2016-10-28

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Merz Investigative Site#001261 — College Station, Texas, United States
• Merz Investigative Site#180001 — Santo Domingo, Dominican Republic
• Merz Investigative Site #504001 — San Pedro Sula, Honduras

Full record on ClinicalTrials.gov

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