Phase 4 N=56 Treatment

Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

Tinea Pedis · Tinea Cruris

Bottom Line

View on ClinicalTrials.gov: NCT01712360 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose — 138262.2; 15890.1; 68634.2; 17213.9 h*pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: NAFT500 (pediatric) (Drug); NAFT600 (pediatric) (Drug); NAFT500 (adult) (Drug); NAFT600 (adult) (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Merz North America, Inc.
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose	9213.35; 1397.77; 3983.34; 1741.02; 12727.36; 3813.38	—
PRIMARY Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose	9213.35; 1397.77; 3983.34; 1741.02; 12727.36; 3813.38	—
SECONDARY Efficacy Variables	81.8; 0; 86.4; 16.7; 54.5; 20.0	—
SECONDARY Efficacy Variables	81.8; 0; 86.4; 16.7; 54.5; 20.0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01712360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.