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An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

NCT ID: NCT02466867

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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Conditions

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Tinea Corporis

Keywords

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Ringworm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Naftin® Cream, 2% (younger pediatric cohort)

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

Group Type EXPERIMENTAL

Naftin® Cream, 2% (younger pediatric cohort)

Intervention Type 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% (older pediatric cohort)

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

Group Type EXPERIMENTAL

Naftin® Cream, 2% (older pediatric cohort)

Intervention Type DRUG

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

Interventions

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Naftin® Cream, 2% (younger pediatric cohort)

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

Naftin® Cream, 2% (older pediatric cohort)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan B. Fleischer, MD

Role: STUDY_DIRECTOR

Merz North America, Inc.

Locations

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Merz Investigative Site#001261

College Station, Texas, United States

Site Status

Merz Investigative Site#180001

Santo Domingo, , Dominican Republic

Site Status

Merz Investigative Site #504001

San Pedro Sula, , Honduras

Site Status

Countries

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United States Dominican Republic Honduras

Other Identifiers

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MUS90200_4025_1

Identifier Type: -

Identifier Source: org_study_id