Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

Tinea Pedis Clinical Trial

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

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

• Tinea
• Tinea Cruris
• Tinea Pedis

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