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Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712360
First Posted: October 23, 2012
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merz North America, Inc.
  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 has 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
Intervention Model: Parallel Assignment
Masking: None (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 North America, Inc.:

Primary Outcome Measures:
  • 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


  • 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 Outcome Measures:
  • 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

  • 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



Enrollment: 56
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
  • naftifine hydrochloride
Experimental: NAFT600 (pediatric)
Topical once a day for two weeks
Drug: NAFT600 (pediatric)
Applied to both feet only
Other Names:
  • NAFT600
  • naftifine
  • naftifine hydrochloride
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:
  • NAFT600
  • naftifine
  • naftifine hydrochloride

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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, or atopic or contact dermatitis
  • Positive pregnancy test
  • Any history or current evidence (physical or laboratory) of anemia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712360


Locations
United States, Texas
Merz Investigative Site #001272
Austin, Texas, United States, 78759
Merz Investigative Site #001261
College Station, Texas, United States, 77802
Dominican Republic
Merz Investigative Site #180001
Santo Domingo, Dominican Republic
Honduras
Merz Investigative Site #504001
San Pedro Sula, Honduras
Sponsors and Collaborators
Merz North America, Inc.
Investigators
Study Director: Alan Fleischer, MD Merz Pharmaceutical, LLC
  More Information

Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01712360     History of Changes
Other Study ID Numbers: MUS 90200/1023/0
Tinea Pedis and Cruris
First Submitted: October 16, 2012
First Posted: October 23, 2012
Results First Submitted: April 14, 2016
Results First Posted: July 14, 2016
Last Update Posted: July 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Merz North America, Inc.:
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