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

NCT01696799 | Completed Phase 2

• 1 other identifier: 079-2951-109
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interdigital Tinea Pedis

Outcome Measures

Primary Outcomes (2)

• Plasma Levels of Econazole Nitrate

  Blood will be taken at Baseline (Day 1) prior to the application of medication, and at the end of treatment (Day 28), just prior to the last dose of medication, and at 7 (±1 hr) hours post-drug application and a third blood draw 4 (±1 hr) hours after the second PK blood draw.

  28 Days

• Investigator Assessment of Response to Treatment

  At the end of treatment (Day 28), the Investigator will assess the subject's response to treatment using a 5-point scale (1 = excellent, 2 = very good, 3 = good, 4 = fair, and 5 = poor).

  28 Days

Secondary Outcomes (1)

• Dosing Compliance

  28 Days

Study Arms (3)

Econazole Nitrate Foam

EXPERIMENTAL

Investigational Drug Product

Drug: Econazole Nitrate

Vehicle Foam

PLACEBO COMPARATOR

Vehicle Foam Comparator

Drug: placebo

Econazole Nitrate Cream

ACTIVE COMPARATOR

Active comparator cream product

Drug: Econazole Nitrate

Interventions

Econazole Nitrate DRUG

Econazole Nitrate Cream; Econazole Nitrate Foam

placebo DRUG

Vehicle Foam

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• AmDerma: lead
• AmDerma Pharmaceuticals, LLC: collaborator

Study Sites (1)

Therapeutics Inc.

San Diego, California, 92123, United States

Location

MeSH Terms

Interventions

Econazole

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 1, 2012
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

US (1)