Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis

Tinea Pedis Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Vehicle Controlled, Parallel Group Comparison of Econazole Nitrate Foam 1% vs Foam Vehicle and an Evaluator-Blinded Comparison of Econazole Nitrate Foam 1% and Econazole Nitrate Cream 1% in Subjects With Interdigital Tinea Pedis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358240
• Other study ID #: 079-2951-303
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2011
• Last updated: September 27, 2012
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: September 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 study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Be at least 12 years of age and of either sex.

• Have a clinical diagnosis of interdigital tinea pedis involving at least 2 web spaces in total which extends no more than approximately 1 inch proximal to the web spaces or metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms (Section 10.1) at baseline.

• Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.

• 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. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. 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.

• Females must be non-pregnant (confirmed by a negative urine pregnancy test (UPT) at baseline), 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 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 used systemic antibacterials or systemic corticosteroids within 30 days prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.

• Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).

• Has concurrent tinea infection e.g. tinea versicolor, tinea cruris, moccasin-type tinea pedis, etc. (in the opinion of the Investigator).

• Onychomycosis, involving = 20% of the area of either great toenail or involvement of more than five toenails in total.

• 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
• Tinea Pedis

Intervention

Drug:
• Econazole Nitrate Foam 1%
Econazole Nitrate Foam 1% applied once a day for 4 weeks
• Vehicle Foam
Vehicle Foam applied once a day for 4 week
• Econazole Nitrate Cream 1%
Econazole Nitrate Foam 1% applied once a day for 4 weeks

Other:
• Placebo Cream
Placebo cream applied once a day for 4 weeks

Locations

Country	Name	City	State
United States	Michael T. Jarratt, MD	Austin	Texas
United States	Marta I. Rendon, MD	Boca Raton	Florida
United States	William Abramovits, MD	Dallas	Texas
United States	Sunil S. Dhawan, MD	Fremont	California
United States	Steven E. Kempers, MD	Fridley	Minnesota
United States	Guy F. Webster, MD, PhD	Hockessin	Delaware
United States	Jonathan Kantor, MD	Jacksonville	Florida
United States	Edward J. Primka III, MD	Knoxville	Tennessee
United States	Harry H. Sharata, MD, PhD	Madison	Wisconsin
United States	David M. Pariser, MD, FAAD, FACP	Norfolk	Virginia
United States	Joel Schlessinger, MD	Omaha	Nebraska
United States	Phoebe Rich, MD	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
AmDerma	AmDerma Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Cure	Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and system at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.	Day 43	No
Secondary	Effective Treatment	Effective Treatment defined as 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, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.	Day 43	No
Secondary	Mycological Cure	Mycological Cure defined as negative KOH and negative culture at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.	Day 43	No