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

This study has been completed.
Sponsor:
Collaborator:
AmDerma Pharmaceuticals, LLC
Information provided by (Responsible Party):
AmDerma
ClinicalTrials.gov Identifier:
NCT01696799
First received: September 27, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Interdigital Tinea Pedis
Drug: Econazole Nitrate
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized Comparative Study of the Pharmacokinetics of Econazole Nitrate 1% Foam and Econazole Nitrate 1% Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years

Resource links provided by NLM:


Further study details as provided by AmDerma:

Primary Outcome Measures:
  • Plasma Levels of Econazole Nitrate [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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.

  • Investigator Assessment of Response to Treatment [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Dosing Compliance [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    Measures of study medication compliance will include the total number of applications, duration of treatment, and the total amount of study medication used. The amount of study medication used will be determined post-study following thereturn of all clinical supplies.


Enrollment: 42
Study Start Date: September 2011
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Econazole Nitrate Foam
Investigational Drug Product
Drug: Econazole Nitrate
Placebo Comparator: Vehicle Foam
Vehicle Foam Comparator
Drug: placebo
Active Comparator: Econazole Nitrate Cream
Active comparator cream product
Drug: Econazole Nitrate

Detailed Description:

Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle in adults, the current clinical study is being conducted to provide additional pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in this pediatric population. The study also includes clinical and safety endpoints.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696799

Locations
United States, California
Therapeutics Inc.
San Diego, California, United States, 92123
Sponsors and Collaborators
AmDerma
AmDerma Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: AmDerma
ClinicalTrials.gov Identifier: NCT01696799     History of Changes
Other Study ID Numbers: 079-2951-109
Study First Received: September 27, 2012
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Econazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014