Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

Phase 4

Completed

• Conditions: Tinea Cruris; Tinea Pedis
• Interventions: Drug: NAFT600 (pediatric); Drug: NAFT600 (adult); Drug: NAFT500 (pediatric); Drug: NAFT500 (adult)

• Registration Number: NCT01712360
• Lead Sponsor: Merz North America, Inc.

Brief 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-23
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2016-04-14
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-03
• Last Update Submitted: 2016-06-03
• Results First Posted: 2016-07-14
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAFT600 (pediatric)	NAFT600 (pediatric)	Topical once a day for two weeks
NAFT600 (adult)	NAFT600 (adult)	Topical once a day for two weeks
NAFT500 (pediatric)	NAFT500 (pediatric)	Topical once a day for two weeks
NAFT500 (adult)	NAFT500 (adult)	Topical once a day for two weeks

Primary Outcome Measures

Name	Time	Method
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose	Day 1 and Day 14	Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.; Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).

Secondary Outcome Measures

Name	Time	Method
Efficacy Variables	Day 28	Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).; Efficacy variables to be analyzed: - Subject satisfaction

Trial Locations

Locations (4)

Merz Investigative Site #001261; 🇺🇸 College Station, Texas, United States

Merz Investigative Site #180001; 🇩🇴 Santo Domingo, Dominican Republic

Merz Investigative Site #504001; 🇭🇳 San Pedro Sula, Honduras

Merz Investigative Site #001272; 🇺🇸 Austin, Texas, United States