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A Study of Econazole Foam 1% in Athlete's Foot

Primary Purpose

Tinea Pedis, Athlete's Foot

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Econazole Nitrate Cream 1%

Econazole Nitrate Foam 1%

Vehicle Foam

About this trial

This is an interventional treatment trial for Tinea Pedis focused on measuring Econazole, Foam, Quinnova

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be at least 18 years or age and of either sex.
Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
Be willing to give informed consent.
Be willing and able to give informed consent.
Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the 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.
Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).

Exclusion Criteria:

Is nursing or planning a pregnancy during the study.
Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 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 a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
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.

Sites / Locations

Stacy Smith, MD
Daniel Stewart, DO
Steven Kempers, MD
Michael Gold, MD
Michael Jarratt, MD
Leonard Swinyer, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Arm Description

Econazole Nitrate Cream 1%

Econazole Nitrate Foam 1%

Vehicle Foam

Outcomes

Primary Outcome Measures

Complete Cure Rate: Interdigital Disease

A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.

Complete Cure Rate: Moccasin Disease

A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.

Secondary Outcome Measures

Effective Treatment: Interdigital Disease

Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).

Effective Treatment: Mocassin Disease

Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).

Mycological Cure: Interdigital Disease

Negative KOH and negative fungal culture at Day 43

Mycological Cure: Mocassin Disease

Negative KOH and negative fungal culture at Day 43

Full Information

NCT ID

NCT00768599

First Posted

October 7, 2008

Last Updated

December 5, 2012

Sponsor

AmDerma

1. Study Identification

Unique Protocol Identification Number

NCT00768599

Brief Title

A Study of Econazole Foam 1% in Athlete's Foot

Official Title

A Multi-Center Randomized, Evaluator-Blinded, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1%, Econazole Nitrate 1% Cream, and Foam Vehicle in Subjects With Tinea Pedis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AmDerma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.

Detailed Description

Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinea Pedis, Athlete's Foot

Keywords

Econazole, Foam, Quinnova

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Econazole Nitrate Cream 1%

Arm Title

Arm Type

Experimental

Arm Description

Econazole Nitrate Foam 1%

Arm Title

Arm Type

Placebo Comparator

Arm Description

Vehicle Foam

Intervention Type

Drug

Intervention Name(s)

Econazole Nitrate Cream 1%

Other Intervention Name(s)

Econazole Nitrate Cream 1%, Fougera - Altana Inc.

Intervention Description

Topical cream, applied once daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Econazole Nitrate Foam 1%

Other Intervention Name(s)

Quinnova Econazole Nitrate Foam 1%

Intervention Description

Topical foam, applied once daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Vehicle Foam

Other Intervention Name(s)

Quinnova Foam Vehicle

Intervention Description

Topical foam, applied once daily for 4 weeks.

Primary Outcome Measure Information:

Title

Complete Cure Rate: Interdigital Disease

Description

A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.

Time Frame

Day 43

Title

Complete Cure Rate: Moccasin Disease

Description

A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.

Time Frame

43 Days

Secondary Outcome Measure Information:

Title

Effective Treatment: Interdigital Disease

Description

Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).

Time Frame

Title

Effective Treatment: Mocassin Disease

Description

Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).

Time Frame

Title

Mycological Cure: Interdigital Disease

Description

Negative KOH and negative fungal culture at Day 43

Time Frame

Title

Mycological Cure: Mocassin Disease

Description

Negative KOH and negative fungal culture at Day 43

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be at least 18 years or age and of either sex. Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only). Be willing to give informed consent. Be willing and able to give informed consent. Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the 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. Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal). Exclusion Criteria: Is nursing or planning a pregnancy during the study. Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 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 a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications). Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed. 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.

Facility Information:

Facility Name

Stacy Smith, MD

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Daniel Stewart, DO

City

Clinton Township

State/Province

Michigan

ZIP/Postal Code

48038

Country

United States

Facility Name

Steven Kempers, MD

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Michael Gold, MD

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Michael Jarratt, MD

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Leonard Swinyer, MD

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

12. IPD Sharing Statement

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A Study of Econazole Foam 1% in Athlete's Foot

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