An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Com… (NCT01110330) | Clinical Trial Compass
TerminatedPhase 3
An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot
Stopped: Unexpected discordant results between the KOH microscopy and mycological culture tests at three study sites in the UK.
Poland, United Kingdom583 participantsStarted 2007-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 uncontroll…
What they're measuring
1
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6
Timeframe: Week 6
Trial details
NCT IDNCT01110330
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.