Phase 2
N=135
A Study of Econazole Foam 1% in Athlete's Foot
Tinea Pedis · Athlete's Foot
Bottom Line
View on ClinicalTrials.gov: NCT00768599 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Complete Cure Rate: Interdigital Disease — 9; 9; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Econazole Nitrate Cream 1% (Drug); Econazole Nitrate Foam 1% (Drug); Vehicle Foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AmDerma
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Cure Rate: Interdigital Disease |
9; 9; 1 | — |
| PRIMARY Complete Cure Rate: Moccasin Disease |
2; 0; 0 | — |
| SECONDARY Effective Treatment: Interdigital Disease |
21; 16; 1 | — |
| SECONDARY Effective Treatment: Mocassin Disease |
3; 4; 0 | — |
| SECONDARY Mycological Cure: Interdigital Disease |
27; 20; 4 | — |
| SECONDARY Mycological Cure: Mocassin Disease |
5; 5; 1 | — |
Summary
This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years or age and of either sex.
- Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
- Be willing to give informed consent.
- Be willing and able to give informed consent.
- Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the 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.
- Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).
Exclusion Criteria
- Is nursing or planning a pregnancy during the study.
- Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 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 a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
- Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
- 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.
Data sourced from ClinicalTrials.gov (NCT00768599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.