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

NCT01358240 | Completed Phase 3

• 1 other identifier: 079-2951-303
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Tinea Pedis; Athlete's Foot

Keywords

Econazole Nitrate; Foam; Quinnova; Tinea Pedis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Effective Treatment

  Day 43

• Mycological Cure

  Day 43

Study Arms (4)

Econazole Nitrate Foam 1%

EXPERIMENTAL

Study medication

Drug: Econazole Nitrate Foam 1%

Vehicle Foam

PLACEBO COMPARATOR

Placebo medication

Drug: Vehicle Foam

Econazole Nitrate Cream 1%

ACTIVE COMPARATOR

Econazole Nitrate Cream 1%

Drug: Econazole Nitrate Cream 1%

Placebo Cream

SHAM COMPARATOR

Placebo Cream

Other: Placebo Cream

Interventions

Econazole Nitrate Foam 1% DRUG

Econazole Nitrate Foam 1% applied once a day for 4 weeks

Econazole Nitrate Foam 1%

Vehicle Foam DRUG

Vehicle Foam applied once a day for 4 week

Vehicle Foam

Econazole Nitrate Cream 1% DRUG

Econazole Nitrate Foam 1% applied once a day for 4 weeks

Econazole Nitrate Cream 1%

Placebo Cream OTHER

Placebo cream applied once a day for 4 weeks

Placebo Cream

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AmDerma: lead
• AmDerma Pharmaceuticals, LLC: collaborator

Study Sites (12)

Sunil S. Dhawan, MD

Fremont, California, 94538, United States

Location

Guy F. Webster, MD, PhD

Hockessin, Delaware, 19707, United States

Location

Marta I. Rendon, MD

Boca Raton, Florida, 33486, United States

Location

Jonathan Kantor, MD

Jacksonville, Florida, 32204, United States

Location

Steven E. Kempers, MD

Fridley, Minnesota, 55432, United States

Location

Joel Schlessinger, MD

Omaha, Nebraska, 68144, United States

Location

Phoebe Rich, MD

Portland, Oregon, 97210, United States

Location

Edward J. Primka III, MD

Knoxville, Tennessee, 37917, United States

Location

Michael T. Jarratt, MD

Austin, Texas, 78759, United States

Location

William Abramovits, MD

Dallas, Texas, 75230, United States

Location

David M. Pariser, MD, FAAD, FACP

Norfolk, Virginia, 23507, United States

Location

Harry H. Sharata, MD, PhD

Madison, Wisconsin, 53719, 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

Study Officials

• Daniel Piacquadio, MD

  Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

US (12)