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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis; Tinea Cruris
• Intervention / Treatment: Drug: NAFT500 (pediatric); Drug: NAFT600 (pediatric); Drug: NAFT500 (adult); Drug: NAFT600 (adult)

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Merz Investigative Site #180001
• Honduras
  • San Pedro Sula, Honduras
    • Merz Investigative Site #504001
• United States
  • Texas
    • Austin, Texas, United States, 78759
      • Merz Investigative Site #001272
    • College Station, Texas, United States, 77802
      • Merz Investigative Site #001261

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAFT500 (pediatric); Topical once a day for two weeks	Drug: NAFT500 (pediatric); Applied to both feet and groin area; Other Names: NAFT500; naftifine; naftifine hydrochloride
Experimental: NAFT600 (pediatric); Topical once a day for two weeks	Drug: NAFT600 (pediatric); Applied to both feet only; Other Names: naftifine; naftifine hydrochloride; NAFT600
Experimental: NAFT500 (adult); Topical once a day for two weeks	Drug: NAFT500 (adult); Applied to both feet and groin area; Other Names: NAFT500; naftifine; naftifine hydrochloride
Experimental: NAFT600 (adult); Topical once a day for two weeks	Drug: NAFT600 (adult); Applied to both feet; Other Names: naftifine; naftifine hydrochloride; NAFT600

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose	Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: - Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: - Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state	Day 1 and Day 14
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose	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).	Day 1 and Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Variables	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: Complete cure; Treatment effectiveness; Mycological cure; Clinical success; Clinical cure	Day 28
Efficacy Variables	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	Day 28

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Alan Fleischer, MD, Merz Pharmaceutical, LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Tinea Pedis; Tinea Cruris; Athlete foot; Jock itch
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatitis; Skin Diseases, Eczematous; Dermatomycoses; Foot Dermatoses; Pruritus; Intertrigo; Tinea; Tinea Pedis; Tinea cruris; Anti-Infective Agents; Antifungal Agents; Naftifine
• Other Study ID Numbers: MUS 90200/1023/0; Tinea Pedis and Cruris

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO