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

This study has been completed.
Sponsor:
Collaborator:
AmDerma Pharmaceuticals, LLC
Information provided by (Responsible Party):
AmDerma
ClinicalTrials.gov Identifier:
NCT01358240
First received: May 19, 2011
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Tinea Pedis
Athlete's Foot
Drug: Econazole Nitrate Foam 1%
Drug: Vehicle Foam
Drug: Econazole Nitrate Cream 1%
Other: Placebo Cream
Phase 3

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, 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

Resource links provided by NLM:


Further study details as provided by AmDerma:

Primary Outcome Measures:
  • Complete Cure [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Effective Treatment [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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.

  • Mycological Cure [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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.


Enrollment: 336
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Econazole Nitrate Foam 1%
Study medication
Drug: Econazole Nitrate Foam 1%
Econazole Nitrate Foam 1% applied once a day for 4 weeks
Placebo Comparator: Vehicle Foam
Placebo medication
Drug: Vehicle Foam
Vehicle Foam applied once a day for 4 week
Active Comparator: Econazole Nitrate Cream 1%
Econazole Nitrate Cream 1%
Drug: Econazole Nitrate Cream 1%
Econazole Nitrate Foam 1% applied once a day for 4 weeks
Sham Comparator: Placebo Cream
Placebo Cream
Other: Placebo Cream
Placebo cream applied once a day for 4 weeks

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01358240

Locations
United States, California
Sunil S. Dhawan, MD
Fremont, California, United States, 94538
United States, Delaware
Guy F. Webster, MD, PhD
Hockessin, Delaware, United States, 19707
United States, Florida
Marta I. Rendon, MD
Boca Raton, Florida, United States, 33486
Jonathan Kantor, MD
Jacksonville, Florida, United States, 32204
United States, Minnesota
Steven E. Kempers, MD
Fridley, Minnesota, United States, 55432
United States, Nebraska
Joel Schlessinger, MD
Omaha, Nebraska, United States, 68144
United States, Oregon
Phoebe Rich, MD
Portland, Oregon, United States, 97210
United States, Tennessee
Edward J. Primka III, MD
Knoxville, Tennessee, United States, 37917
United States, Texas
Michael T. Jarratt, MD
Austin, Texas, United States, 78759
William Abramovits, MD
Dallas, Texas, United States, 75230
United States, Virginia
David M. Pariser, MD, FAAD, FACP
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Harry H. Sharata, MD, PhD
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
AmDerma
AmDerma Pharmaceuticals, LLC
Investigators
Study Director: Daniel Piacquadio, MD Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: AmDerma
ClinicalTrials.gov Identifier: NCT01358240     History of Changes
Other Study ID Numbers: 079-2951-303
Study First Received: May 19, 2011
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AmDerma:
Econazole Nitrate
Foam
Quinnova
Tinea Pedis

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

ClinicalTrials.gov processed this record on August 28, 2014