Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Inter… (NCT01696799) | Clinical Trial Compass
CompletedPhase 2
Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years
United States42 participantsStarted 2011-09
Plain-language summary
To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion Criteria:
* Be between 12 years and less than 18 years of age and of either sex.
* Have a clinical diagnosis of interdigital tinea pedis
* Parent/guardian has provided written informed consent and the subject has provided written assent.
* Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
* Have microscopic evidence (positive KOH) of the presence of fungi and a positive fungal culture.
* Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
* Females must be non-pregnant, non-lactating and not intending to become pregnant during the course of the study.
Exclusion Criteria:
* Is pregnant, nursing or planning a pregnancy during the study
* Has used topical antifungals or topical corticosteroids on the feet within 14 days prior to the start of the study.
* Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
* Has used systemic antibacterials or systemic corticosteroids within 14 days prior to the start of the study.
* Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
* Has concurrent moccasin-type tinea pedis (in the opinion of the Investigator).
* Has any other skin disease which might interfere with the evaluation of tinea pedis.
* Is currently …