NCT02466867

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

October 29, 2014

Last Update Submit

October 27, 2016

Conditions

Tinea Corporis

Keywords

Ringworm

Outcome Measures

Primary Outcomes (1)

  • 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

    2 weeks

Secondary Outcomes (3)

  • Evaluate plasma PK single and multiple dose PK variables

    2 weeks

  • Evaluate trough plasma PK concentration

    2 weeks

  • Evaluate urine PK single and multiple dose variables

    2 weeks

Study Arms (2)

Naftin® Cream, 2% (younger pediatric cohort)

EXPERIMENTAL

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

Drug: Naftin® Cream, 2% (younger pediatric cohort)

Naftin® Cream, 2% (older pediatric cohort)

EXPERIMENTAL

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

Drug: Naftin® Cream, 2% (older pediatric cohort)

Interventions

Naftin® Cream, 2% (younger pediatric cohort)DRUG

Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.

Naftin® Cream, 2% (younger pediatric cohort)
Naftin® Cream, 2% (older pediatric cohort)DRUG

Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.

Naftin® Cream, 2% (older pediatric cohort)

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Merz Investigative Site#001261

College Station, Texas, 77845, United States

Location

Merz Investigative Site#180001

Santo Domingo, Dominican Republic

Location

Merz Investigative Site #504001

San Pedro Sula, Honduras

Location

MeSH Terms

Conditions

Tinea

Condition Hierarchy (Ancestors)

DermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alan B. Fleischer, MD

    Merz North America, Inc.

    STUDY DIRECTOR

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 29, 2014

First Posted

June 9, 2015

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

DO(1)US(1)HO(1)