Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AmDerma
ClinicalTrials.gov Identifier:
NCT00768599
First received: October 7, 2008
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Tinea Pedis
Athlete's Foot
Drug: Econazole Nitrate Cream 1%
Drug: Econazole Nitrate Foam 1%
Drug: Vehicle Foam
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AmDerma:

Primary Outcome Measures:
  • Complete Cure Rate: Interdigital Disease [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 43 Days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 43 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 43 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 43 ] [ Designated as safety issue: No ]
    Negative KOH and negative fungal culture at Day 43

  • Mycological Cure: Mocassin Disease [ Time Frame: 43 ] [ Designated as safety issue: No ]
    Negative KOH and negative fungal culture at Day 43


Enrollment: 135
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Econazole Nitrate Cream 1%
Drug: Econazole Nitrate Cream 1%
Topical cream, applied once daily for 4 weeks.
Other Name: Econazole Nitrate Cream 1%, Fougera - Altana Inc.
Experimental: 2
Econazole Nitrate Foam 1%
Drug: Econazole Nitrate Foam 1%
Topical foam, applied once daily for 4 weeks.
Other Name: Quinnova Econazole Nitrate Foam 1%
Placebo Comparator: 3
Vehicle Foam
Drug: Vehicle Foam
Topical foam, applied once daily for 4 weeks.
Other Name: Quinnova Foam Vehicle

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768599

Locations
United States, California
Stacy Smith, MD
San Diego, California, United States, 92123
United States, Michigan
Daniel Stewart, DO
Clinton Township, Michigan, United States, 48038
United States, Minnesota
Steven Kempers, MD
Fridley, Minnesota, United States, 55432
United States, Tennessee
Michael Gold, MD
Nashville, Tennessee, United States, 37215
United States, Texas
Michael Jarratt, MD
Austin, Texas, United States, 78759
United States, Utah
Leonard Swinyer, MD
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
AmDerma
  More Information

No publications provided

Responsible Party: AmDerma
ClinicalTrials.gov Identifier: NCT00768599     History of Changes
Other Study ID Numbers: D79-2902-07
Study First Received: October 7, 2008
Results First Received: December 5, 2012
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AmDerma:
Econazole
Foam
Quinnova

Additional relevant MeSH terms:
Tinea Pedis
Dermatomycoses
Foot Dermatoses
Foot Diseases
Infection
Mycoses
Pruritus
Signs and Symptoms
Skin Diseases
Skin Diseases, Infectious
Skin Manifestations
Tinea
Econazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014