Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01712360
First received: October 16, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 have both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.


Condition Intervention Phase
Tinea Pedis
Tinea Cruris
Drug: NAFT500 (pediatric)
Drug: NAFT600 (pediatric)
Drug: NAFT500 (adult)
Drug: NAFT600 (adult)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Naftifine hydrochloride pharmacokinetics variables, single and multiple dose [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]

    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), calculated using the linear trapezoid rule.
    • 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:

    • Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state .
    • Maximum observed plasma concentration (Cmax); the highest plasma concentration in each subject at steady state


Secondary Outcome Measures:
  • Efficacy variables [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

    " 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
    • Subject satisfaction

  • Time of maximum naftifine plasma concentration after single dose and steady state multiple dose. [ Time Frame: Day 1 and day 14 ] [ Designated as safety issue: No ]

    Variables will be derived from naftifine plasma concentration at predetermined timepoints.

    Trough naftifine plasma concentration variables:

    • Trough plasma concentrations
    • Time (days) to maximal trough plasma concentration
    • Maximum observed trough plasma concentration; the highest trough plasma concentration in each subject

  • Naftifine hydrochloride pharmacokinetic variables in Urine, single dose and multiple dose [ Time Frame: Day 1 and day 14 ] [ Designated as safety issue: No ]

    Variables will be derived from naftifine urine concentration at predetermined timepoints day 1 and day 14. Variables to be analyzed:

    • Partial amount of unchanged drug excreted into urine within the first 24 hours after single dose
    • Fraction of administrated drug excreted into urine (%)
    • Renal clearance

    After multiple doses

    • Amount of unchanged drug excreted into urine during a dosing interval at steady state
    • Fraction of administrated drug excreted into urine during a dosing interval at steady state
    • Renal clearance


Enrollment: 65
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAFT500 (pediatric)
Topical once a day for two weeks
Drug: NAFT500 (pediatric)
Applied to both feet and groin area
Other Names:
  • NAFT500
  • naftifine
Experimental: NAFT600 (pediatric)
Topical once a day for two weeks
Drug: NAFT600 (pediatric)
Applied to both feet only
Other Names:
  • NAFT600
  • naftifine
Experimental: NAFT500 (adult)
Topical once a day for two weeks
Drug: NAFT500 (adult)
Applied to both feet and groin area
Other Names:
  • NAFT500
  • naftifine
Experimental: NAFT600 (adult)
Topical once a day for two weeks
Drug: NAFT600 (adult)
Applied to both feet
Other Names:
  • NAFT600
  • naftifine

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 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 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 KOH analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 PK evaluable adult subjects with the same condition will serve as a control.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, atopic or contact dermatitis.
  • Positive pregnancy test
  • Any history or current evidence(physical or laboratory) of anemia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712360

Locations
United States, Texas
Merz Investigative Site# 001272
Austin, Texas, United States, 78759
Merz Investigative Site #0001
College Station, Texas, United States, 77845
Dominican Republic
Merz Investigative Site# 180001
Santo Domingo, Dominican Republic
Honduras
Merz Investigative Site# 504001
San Pedro Sula, Honduras
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Study Director: Stefan Plaum, MD Merz Pharmaceutical, LLC
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01712360     History of Changes
Other Study ID Numbers: MUS 90200/1023/0, Tinea Pedis and Cruris
Study First Received: October 16, 2012
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals, LLC:
Tinea Pedis
Tinea Cruris
Athlete foot
Jock itch

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Naftifine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014