Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Bo… (NCT01580878) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis
707 participantsStarted 2012-01
Plain-language summary
The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing \& able to provide \& understand written informed consent
* Healthy male or non-pregnant, non-lactating female at least 18 years of age and older
* Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or that is predominantly interdigital but may extend to other areas
* Tinea pedis provisionally confirmed at baseline by positive potassium hydroxide (KOH)wet mount preparation showing segmented fungal hyphae
* Has sum of the clinical signs and symptoms scores of the target lesion of at least 4, including a minimum score of 2 for erythema \& a minimum score of 2 for scaling or pruritus
* Currently in general good health with no clinically significant disease
* Willing and able to understand and comply with study requirements
* Women of childbearing potential must have a negative urine pregnancy test and be willing to use an acceptable form of birth control during study
Exclusion Criteria:
* Females who are pregnant, breastfeeding, planning a pregnancy, or do not agree to use an acceptable form of birth control during the study
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
* Presence of any other infection of the foot or other disease that might confound treatment evaluation
* History of dermatophyte infections unresponsive to antifungal drugs
* Known hypersensitivity to Butenafine Hydrochloride or any component of the study medications
* Use of antipruritics, topical systemic corticost…