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

Completed · Phase 2 · Has a placebo group

Conditions studied: Interdigital Tinea Pedis

In brief

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.

Key facts

Study ID

NCT01696799

Run by

AmDerma

People needed

42

Starts

2011-09-01

Expected to finish

2012-08-01

Last updated by the study team

2012-10-01

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 enrolled in an investigational drug or device study.
• Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
• Is unreliable, including subjects with a history of drug or alcohol abuse.
• Has known hypersensitivity to any of the components of the study medications.

Where it is running

• Therapeutics Inc. — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.