Skip to main content
OpenTrials
Completed

NCT Number: NCT01712360

Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatitis Dermatomycoses Foot Dermatoses Foot Diseases Infections Intertrigo Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea Tinea Cruris

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Merz Investigative Site #180001, Santo Domingo, Santo Domingo Province, Dominican Republic

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NAFT500 (pediatric)

Drug

Applied to both feet and groin area

Other names: NAFT500, naftifine, naftifine hydrochloride

NAFT600 (pediatric)

Drug

Applied to both feet only

Other names: NAFT600, naftifine, naftifine hydrochloride

NAFT500 (adult)

Drug

Applied to both feet and groin area

Other names: NAFT500, naftifine, naftifine hydrochloride

NAFT600 (adult)

Drug

Applied to both feet

Other names: NAFT600, naftifine, naftifine hydrochloride

Primary outcomes

  1. Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose

    Time frame: Day 1 and Day 14

    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

  2. Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose

    Time frame: 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 outcomes

  1. Efficacy Variables

    Time frame: 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:

    • Complete cure
    • Treatment effectiveness
    • Mycological cure
    • Clinical success
    • Clinical cure

  2. Efficacy Variables

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 23, 2012
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.