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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768599
• Other study ID #: D79-2902-07
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2008
• Last updated: December 5, 2012
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: December 2012
• Source: AmDerma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Athlete's Foot
• Tinea Pedis

Intervention

Drug:
• Econazole Nitrate Cream 1%
Topical cream, applied once daily for 4 weeks.
• Econazole Nitrate Foam 1%
Topical foam, applied once daily for 4 weeks.
• Vehicle Foam
Topical foam, applied once daily for 4 weeks.

Locations

Country	Name	City	State
United States	Michael Jarratt, MD	Austin	Texas
United States	Daniel Stewart, DO	Clinton Township	Michigan
United States	Steven Kempers, MD	Fridley	Minnesota
United States	Michael Gold, MD	Nashville	Tennessee
United States	Leonard Swinyer, MD	Salt Lake City	Utah
United States	Stacy Smith, MD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
AmDerma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 43	No
Primary	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.	43 Days	No
Secondary	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).	43	No
Secondary	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).	43	No
Secondary	Mycological Cure: Interdigital Disease	Negative KOH and negative fungal culture at Day 43	43	No
Secondary	Mycological Cure: Mocassin Disease	Negative KOH and negative fungal culture at Day 43	43	No