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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01712360
Other study ID # MUS 90200/1023/0
Secondary ID Tinea Pedis and
Status Completed
Phase Phase 4
First received October 16, 2012
Last updated August 1, 2014
Start date October 2012
Est. completion date November 2013

Study information

Verified date August 2014
Source Merz Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
NAFT500 (pediatric)
Applied to both feet and groin area
NAFT600 (pediatric)
Applied to both feet only
NAFT500 (adult)
Applied to both feet and groin area
NAFT600 (adult)
Applied to both feet

Locations

Country Name City State
Dominican Republic Merz Investigative Site# 180001 Santo Domingo
Honduras Merz Investigative Site# 504001 San Pedro Sula
United States Merz Investigative Site# 001272 Austin Texas
United States Merz Investigative Site #0001 College Station Texas

Sponsors (1)

Lead Sponsor Collaborator
Merz Pharmaceuticals, LLC

Countries where clinical trial is conducted

United States,  Dominican Republic,  Honduras, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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), 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
Day 1 and Day 14 No
Secondary 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
Subject satisfaction
2 weeks Yes
Secondary Time of maximum naftifine plasma concentration after single dose and steady state multiple dose. 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
Day 1 and day 14 No
Secondary Naftifine hydrochloride pharmacokinetic variables in Urine, single dose and multiple dose 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
Day 1 and day 14 No
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