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An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

Primary Purpose

Tinea Corporis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Naftin® Cream, 2% (younger pediatric cohort)
Naftin® Cream, 2% (older pediatric cohort)
Sponsored by
Merz North America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Corporis focused on measuring Ringworm

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.
  • Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.
  • KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.
  • Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.

Exclusion Criteria:

  • Tinea infection of the scalp, face, groin, and/or feet.
  • A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months
  • Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
  • Subjects with a known hypersensitivity or other contradictions to study medications or their components.

Sites / Locations

  • Merz Investigative Site#001261
  • Merz Investigative Site#180001
  • Merz Investigative Site #504001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Naftin® Cream, 2% (younger pediatric cohort)

Naftin® Cream, 2% (older pediatric cohort)

Arm Description

Subject aged 2 years to 5 years, 11 months with tinea corporis

Subject aged 6 years to 11 years, 11 months with tinea corporis

Outcomes

Primary Outcome Measures

To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D

Secondary Outcome Measures

Evaluate plasma PK single and multiple dose PK variables
tmax and tmax,ss
Evaluate trough plasma PK concentration
Ctrough, ttrough,max, Ctrough,max
Evaluate urine PK single and multiple dose variables
Ae0-24, fe, CLR, AEt,ss

Full Information

First Posted
October 29, 2014
Last Updated
October 27, 2016
Sponsor
Merz North America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02466867
Brief Title
An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
Official Title
An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Corporis
Keywords
Ringworm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naftin® Cream, 2% (younger pediatric cohort)
Arm Type
Experimental
Arm Description
Subject aged 2 years to 5 years, 11 months with tinea corporis
Arm Title
Naftin® Cream, 2% (older pediatric cohort)
Arm Type
Experimental
Arm Description
Subject aged 6 years to 11 years, 11 months with tinea corporis
Intervention Type
Drug
Intervention Name(s)
Naftin® Cream, 2% (younger pediatric cohort)
Intervention Description
Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.
Intervention Type
Drug
Intervention Name(s)
Naftin® Cream, 2% (older pediatric cohort)
Intervention Description
Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.
Primary Outcome Measure Information:
Title
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
Description
AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Evaluate plasma PK single and multiple dose PK variables
Description
tmax and tmax,ss
Time Frame
2 weeks
Title
Evaluate trough plasma PK concentration
Description
Ctrough, ttrough,max, Ctrough,max
Time Frame
2 weeks
Title
Evaluate urine PK single and multiple dose variables
Description
Ae0-24, fe, CLR, AEt,ss
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test. Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area. KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity. Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations. Exclusion Criteria: Tinea infection of the scalp, face, groin, and/or feet. A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results. Subjects with a known hypersensitivity or other contradictions to study medications or their components.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan B. Fleischer, MD
Organizational Affiliation
Merz North America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Merz Investigative Site#001261
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Merz Investigative Site#180001
City
Santo Domingo
Country
Dominican Republic
Facility Name
Merz Investigative Site #504001
City
San Pedro Sula
Country
Honduras

12. IPD Sharing Statement

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An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

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