An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot
An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot
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.
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor
 the patient knows the name of the assigned treatment), multicentre study in Poland and the
 United Kingdom designed to assess the mycological (fungal) cure rate and clinical efficacy of
 a new formulation of ketoconazole 2% cream (F126) with the current formulation of
 ketoconazole 2% cream (Nizoral) (F012) compared with placebo cream in patients with
 symptomatic uncomplicated interdigital (between the toes) Tinea pedis, a skin infection
 commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.
 Approximately 548 patients who have symptomatic uncomplicated interdigital Tinea pedis
 confirmed by positive potassium hydroxide (KOH) microscopy (examination using a microscope)
 and mycological (fungal) culture will be randomized to receive 1 of 2 formulations of
 ketoconazole 2% cream (formulation F012 or F126) or placebo cream. There will be 4 study
 visits during the study. At Visit 1 (baseline), patients will sign the informed consent and
 be assessed for mycological and clinical signs and symptoms of Tinea pedis. Baseline
 demographics (age, race, etc), medical history and medication (s) that the patient is
 currently taking will be recorded. Patients will be issued with a tube of the cream and
 instructed to apply the cream sparingly to all affected areas of the foot (or feet), once
 daily (at night or in the evenings) for a total of 4 weeks according to protocol-specified
 guidelines. During the 4-week treatment period patients will return to the study every 2
 weeks to be assessed for clinical signs and symptoms. After the 4-week treatment period,
 patients will continue participation in the study for an additional 2 weeks without
 medication. Patients will return then return to the study center for a final visit (Visit 4,
 Week 6) at which time skin scrapings will be sampled from interdigital spaces on both feet
 for KOH microscopy and mycological culture. The primary efficacy endpoint is to determine
 whether a new formulation of ketoconazole 2% cream is equivalent (or as effective) as the
 current formulation of ketoconazole 2% cream (Nizoral) compared to a placebo cream in
 achieving a mycological cure (defined as negative KOH microscopy and negative mycological
 culture) following 4 weeks of treatment. The primary outcome measure in the study is a
 mycological cure (defined as negative KOH microscopy and negative mycological culture) at
 week 6. Patients will be monitored for safety (occurrence of adverse events, use of
 concomitant medications, and reasons for premature discontinuation from the study) from Visit
 1 through Visit 4 (Week 6 or time of early termination from study). Patients will be provided
 with up to two 15g tubes of ketoconazole cream (formulation F126 or F012) or matching placebo
 cream and be instructed to apply cream sparingly to affected areas of the feet once daily at
 night or in the evening for 4 weeks according to protocol specified guidelines.
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