An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis (NCT02466867) | Clinical Trial Compass
CompletedPhase 4
An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
United States, Dominican Republic, Honduras27 participantsStarted 2014-01
Plain-language summary
This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.
Who can participate
Age range2 Years – 11 Years
SexALL
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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.
What they're measuring
1
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis