CompletedPhase 4

Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

United States, Dominican Republic, Honduras56 participantsStarted 2012-10

Plain-language summary

This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.

Who can participate

Age range12 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection. * Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection. Exclusion Criteria: * A known hypersensitivity to study medications or their components * Any severe condition of Tinea pedis (incapacitating) * Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis * Positive pregnancy test * Any history or current evidence (physical or laboratory) of anemia

What they're measuring

Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose

Timeframe: Day 1 and Day 14

Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose

Timeframe: Day 1 and Day 14

Trial details

NCT IDNCT01712360

SponsorMerz North America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2016-04-14

View on ClinicalTrials.gov More Tinea Pedis trials