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

NCT00768599 | Completed Phase 2 Results

• 1 other identifier: D79-2902-07
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 6

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.

Conditions

Tinea Pedis; Athlete's Foot

Keywords

Econazole; Foam; Quinnova

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Effective Treatment: Interdigital Disease

  43

• Effective Treatment: Mocassin Disease

  43

• Mycological Cure: Interdigital Disease

  43

• Mycological Cure: Mocassin Disease

  43

Study Arms (3)

1

ACTIVE COMPARATOR

Econazole Nitrate Cream 1%

Drug: Econazole Nitrate Cream 1%

2

EXPERIMENTAL

Econazole Nitrate Foam 1%

Drug: Econazole Nitrate Foam 1%

3

PLACEBO COMPARATOR

Vehicle Foam

Drug: Vehicle Foam

Interventions

Econazole Nitrate Cream 1% DRUG

Topical cream, applied once daily for 4 weeks.

Also known as: Econazole Nitrate Cream 1%, Fougera - Altana Inc.

1

Econazole Nitrate Foam 1% DRUG

Topical foam, applied once daily for 4 weeks.

Also known as: Quinnova Econazole Nitrate Foam 1%

2

Vehicle Foam DRUG

Topical foam, applied once daily for 4 weeks.

Also known as: Quinnova Foam Vehicle

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AmDerma: lead

Study Sites (6)

Stacy Smith, MD

San Diego, California, 92123, United States

Location

Daniel Stewart, DO

Clinton Township, Michigan, 48038, United States

Location

Steven Kempers, MD

Fridley, Minnesota, 55432, United States

Location

Michael Gold, MD

Nashville, Tennessee, 37215, United States

Location

Michael Jarratt, MD

Austin, Texas, 78759, United States

Location

Leonard Swinyer, MD

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Candis Edwards
• Organization: AmDerma Pharmaceuticals

cedwards@amderma.com

631-974-7949

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 9, 2013
• Results First Posted: January 9, 2013

Record last verified: 2012-12

Locations

US (6)