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Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years

NCT ID: NCT01696799

Last Updated: 2012-10-01

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

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-08-31

Brief Summary

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To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.

Detailed Description

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Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle in adults, the current clinical study is being conducted to provide additional pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in this pediatric population. The study also includes clinical and safety endpoints.

Conditions

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Interdigital Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Econazole Nitrate Foam

Investigational Drug Product

Group Type EXPERIMENTAL

Econazole Nitrate

Intervention Type DRUG

Vehicle Foam

Vehicle Foam Comparator

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Econazole Nitrate Cream

Active comparator cream product

Group Type ACTIVE_COMPARATOR

Econazole Nitrate

Intervention Type DRUG

Interventions

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Econazole Nitrate

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be between 12 years and less than 18 years of age and of either sex.
* Have a clinical diagnosis of interdigital tinea pedis
* Parent/guardian has provided written informed consent and the subject has provided written assent.
* Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
* Have microscopic evidence (positive KOH) of the presence of fungi and a positive fungal culture.
* Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
* Females must be non-pregnant, non-lactating and not intending to become pregnant during the course of the study.

Exclusion Criteria

* Is pregnant, nursing or planning a pregnancy during the study
* Has used topical antifungals or topical corticosteroids on the feet within 14 days prior to the start of the study.
* Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
* Has used systemic antibacterials or systemic corticosteroids within 14 days prior to the start of the study.
* Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
* Has concurrent moccasin-type tinea pedis (in the opinion of the Investigator).
* Has any other skin disease which might interfere with the evaluation of tinea pedis.
* Is currently enrolled in an investigational drug or device study.
* Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
* Is unreliable, including subjects with a history of drug or alcohol abuse.
* Has known hypersensitivity to any of the components of the study medications.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AmDerma Pharmaceuticals, LLC

INDUSTRY

Sponsor Role collaborator

AmDerma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Therapeutics Inc.

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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079-2951-109

Identifier Type: -

Identifier Source: org_study_id