NCT01712360

Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study population, diagnosis, and main criteria for inclusion: Tinea pedis and Tinea cruris (NAFT-500): Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control. Tinea pedis (NAFT-600): Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Conditions

• Tinea Pedis
• Tinea Cruris

Interventions

Type	Name	Description
DRUG	NAFT500 (pediatric)	Applied to both feet and groin area
DRUG	NAFT600 (pediatric)	Applied to both feet only
DRUG	NAFT500 (adult)	Applied to both feet and groin area
DRUG	NAFT600 (adult)	Applied to both feet

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-10-23
• Last updated: 2016-07-14
• Results posted: 2016-07-14

Locations

4 sites across 3 countries: United States, Dominican Republic, Honduras