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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

October 7, 2008
December 5, 2012
March 2008
September 2008   (final data collection date for primary outcome measure)
  • 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.
Complete Cure: defined as 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. [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00768599 on ClinicalTrials.gov Archive Site
  • 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
Effective Treatment: defined as a negative KOH, negative culture, no or mild erythema and/or scaling/hyperkeratosis (score of 0 or 1) with all other signs and symptoms being absent (score = 0) at Day 43. [ Time Frame: Day 29 and 43 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Econazole Foam 1% in Athlete's Foot
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

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Tinea Pedis
  • Athlete's Foot
  • Drug: Econazole Nitrate Cream 1%
    Topical cream, applied once daily for 4 weeks.
    Other Name: Econazole Nitrate Cream 1%, Fougera - Altana Inc.
  • Drug: Econazole Nitrate Foam 1%
    Topical foam, applied once daily for 4 weeks.
    Other Name: Quinnova Econazole Nitrate Foam 1%
  • Drug: Vehicle Foam
    Topical foam, applied once daily for 4 weeks.
    Other Name: Quinnova Foam Vehicle
  • Active Comparator: 1
    Econazole Nitrate Cream 1%
    Intervention: Drug: Econazole Nitrate Cream 1%
  • Experimental: 2
    Econazole Nitrate Foam 1%
    Intervention: Drug: Econazole Nitrate Foam 1%
  • Placebo Comparator: 3
    Vehicle Foam
    Intervention: Drug: Vehicle Foam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
October 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768599
D79-2902-07
No
AmDerma
AmDerma
Not Provided
Not Provided
AmDerma
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP