Status and phase
Conditions
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About
To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.
Enrollment
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Inclusion criteria
Exclusion criteria
Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot;
Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
Subjects who are immunocompromised (due to disease, e.g., HIV or medications
Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
Subjects using the following medications:
Primary purpose
Allocation
Interventional model
Masking
147 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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