Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Study population, diagnosis, and main criteria for inclusion:

Tinea pedis and Tinea cruris (NAFT-500):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Tinea pedis (NAFT-600):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Conditions

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Tinea Pedis Tinea Cruris

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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NAFT500 (pediatric)

Topical once a day for two weeks

Group Type EXPERIMENTAL

NAFT500 (pediatric)

Intervention Type DRUG

Applied to both feet and groin area

NAFT600 (pediatric)

Topical once a day for two weeks

Group Type EXPERIMENTAL

NAFT600 (pediatric)

Intervention Type DRUG

Applied to both feet only

NAFT500 (adult)

Topical once a day for two weeks

Group Type EXPERIMENTAL

NAFT500 (adult)

Intervention Type DRUG

Applied to both feet and groin area

NAFT600 (adult)

Topical once a day for two weeks

Group Type EXPERIMENTAL

NAFT600 (adult)

Intervention Type DRUG

Applied to both feet

Interventions

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NAFT500 (pediatric)

Applied to both feet and groin area

Intervention Type DRUG

NAFT600 (pediatric)

Applied to both feet only

Intervention Type DRUG

NAFT500 (adult)

Applied to both feet and groin area

Intervention Type DRUG

NAFT600 (adult)

Applied to both feet

Intervention Type DRUG

Other Intervention Names

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NAFT500 naftifine naftifine hydrochloride NAFT600 naftifine naftifine hydrochloride NAFT500 naftifine naftifine hydrochloride NAFT600 naftifine naftifine hydrochloride

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No