An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: Placebo cream; Ketoconazole 2% cream (formulation F012) (Nizoral); Ketoconazole 2% cream (formulation F126)
Intervention description: A topical, white, homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.; A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.; A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
Intervention MeSH terms: Ketoconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 583.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tinea Pedis; Ketoconazole (NIZORAL); Antifungal Agents; Miconazole (DAKTARIN)

Summary:

      The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as
      effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo
      in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot"
      that is caused by a kind of mold called a fungus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be co-operative, reliable and sufficiently competent to grade and record symptoms as
             requested

          -  have a clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH
             microscopy

          -  Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, be
             practicing an effective method of birth control before entry and throughout the study
             and have a negative urine pregnancy test at screening (applies to women only)

          -  Sign an informed consent form indicating an understanding of the purpose of and
             procedures required for the study and willingness to participate in the study

        Exclusion Criteria:

          -  Have complicated Tinea pedis defined as confluent, diffuse moccasin type tinea pedis
             of the entire plantar surface (undersurface of foot), onychomycosis (fungal nail
             infection)

          -  other dermatomycosis (fungal skin infection) requiring active treatment

          -  Have a previous sensitivity to imidazole antifungal agents or to any ingredient of the
             study medication

          -  Have a history of disallowed therapies including oral (by mouth) antifungal treatments
             within the previous 6 weeks, recent use (within 2 weeks of the study start) of topical
             antifungal agent, immunosuppressive or radiation therapy within the previous 4 weeks,
             recent use (within 2 weeks prior to screening) of other oral antibiotics, systemic
             corticosteroids or topical corticosteroids or antibiotics applied to the feet

          -  Be HIV-positive (testing will not be performed)

          -  Have uncontrolled diabetes mellitus or peripheral vascular disease requiring active
             treatment