Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

NCT01712360 | Completed Phase 4 Results

• 2 other identifiers: MUS 90200/1023/0Tinea Pedis and Cruris
• Study Type: interventional
• Target: 56
• Locations: 3 countries
• Sites: 4

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

Conditions

Tinea Pedis; Tinea Cruris

Keywords

Tinea Pedis; Tinea Cruris; Athlete foot; Jock itch

Outcome Measures

Primary Outcomes (2)

• 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), 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

  Day 1 and Day 14

• Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose

  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).

  Day 1 and Day 14

Secondary Outcomes (2)

• Efficacy Variables

  Day 28

• Efficacy Variables

  Day 28

Study Arms (4)

NAFT500 (pediatric)

EXPERIMENTAL

Topical once a day for two weeks

Drug: NAFT500 (pediatric)

NAFT600 (pediatric)

EXPERIMENTAL

Topical once a day for two weeks

Drug: NAFT600 (pediatric)

NAFT500 (adult)

EXPERIMENTAL

Topical once a day for two weeks

Drug: NAFT500 (adult)

NAFT600 (adult)

EXPERIMENTAL

Topical once a day for two weeks

Drug: NAFT600 (adult)

Interventions

NAFT500 (pediatric) DRUG

Applied to both feet and groin area

Also known as: NAFT500, naftifine, naftifine hydrochloride

NAFT500 (pediatric)

NAFT600 (pediatric) DRUG

Applied to both feet only

Also known as: NAFT600, naftifine, naftifine hydrochloride

NAFT600 (pediatric)

NAFT500 (adult) DRUG

Applied to both feet and groin area

Also known as: NAFT500, naftifine, naftifine hydrochloride

NAFT500 (adult)

NAFT600 (adult) DRUG

Applied to both feet

Also known as: NAFT600, naftifine, naftifine hydrochloride

NAFT600 (adult)

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (4)

Merz Investigative Site #001272

Austin, Texas, 78759, United States

Location

Merz Investigative Site #001261

College Station, Texas, 77802, United States

Location

Merz Investigative Site #180001

Santo Domingo, Santo Domingo Province, Dominican Republic

Location

Merz Investigative Site #504001

San Pedro Sula, San Pedro Sula, Honduras

Location

MeSH Terms

Conditions

Tinea Pedis; Tinea Cruris

Interventions

naftifine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ashlee Duncan
• Organization: Merz North America, Inc.

Ashlee.Duncan@merz.com

984-222-6040

Study Officials

• Alan Fleischer, MD

  Merz Pharmaceutical, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 23, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 14, 2016
• Results First Posted: July 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); HO (1); US (2)