Back to resultsComparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years
Primary Purpose
Interdigital Tinea Pedis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Econazole Nitrate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Interdigital Tinea Pedis
Eligibility 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.
Sites / Locations
- Therapeutics Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Econazole Nitrate Foam
Vehicle Foam
Econazole Nitrate Cream
Arm Description
Investigational Drug Product
Vehicle Foam Comparator
Active comparator cream product
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Dosing Compliance
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.
Full Information
NCT ID
NCT01696799
First Posted
September 27, 2012
Last Updated
September 28, 2012
Sponsor
AmDerma
Collaborators
AmDerma Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01696799
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AmDerma
Collaborators
AmDerma Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interdigital Tinea Pedis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Econazole Nitrate Foam
Arm Type
Experimental
Arm Description
Investigational Drug Product
Arm Title
Vehicle Foam
Arm Type
Placebo Comparator
Arm Description
Vehicle Foam Comparator
Arm Title
Econazole Nitrate Cream
Arm Type
Active Comparator
Arm Description
Active comparator cream product
Intervention Type
Drug
Intervention Name(s)
Econazole Nitrate
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Plasma Levels of Econazole Nitrate
Description
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.
Time Frame
28 Days
Title
Investigator Assessment of Response to Treatment
Description
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).
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Dosing Compliance
Description
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.
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Therapeutics Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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