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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AmDerma
• Collaborator: AmDerma Pharmaceuticals, LLC
• Treatments: Econazole

Criteria

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 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.