Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

Completed · Phase 4

Conditions studied: Tinea Pedis, Tinea Cruris

In brief

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.

Key facts

Study ID

NCT01712360

Run by

Merz North America, Inc.

People needed

56

Starts

2012-10-01

Expected to finish

2013-11-01

Last updated by the study team

2016-07-14

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Merz Investigative Site #001272 — Austin, Texas, United States
• Merz Investigative Site #001261 — College Station, Texas, United States
• Merz Investigative Site #180001 — Santo Domingo, Santo Domingo Province, Dominican Republic
• Merz Investigative Site #504001 — San Pedro Sula, San Pedro Sula, Honduras

Full record on ClinicalTrials.gov

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