Tinea Pedis
Conditions
Keywords
tinea pedis, athletes foot
Brief summary
This study is designed to evaluate the safety and effectiveness of multiple 1% tolnaftate formulations delivered through novel stick-based vehicles in individuals with tinea pedis (athlete's foot).
Detailed description
To evaluate the efficacy and safety of 1% tolnaftate formulations delivered through novel stick-based vehicles in the treatment of subjects with potassium hydroxide (KOH)-positive tinea pedis.
Interventions
DRUG1% Tolnaftate Stick Formula A
Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
DRUG1% Tolnaftate Stick Formula B
Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
DRUG1% Tolnaftate Stick Formula C
Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.
Sponsors
Propedix, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 16 or above * Clinical diagnosis of tinea pedis (For Cohort 4, positive symptomology is acceptable) * Confirmation of diagnosis with positive potassium hydroxide (KOH) microscopy (For Cohort 4, a negative KOH test is acceptable) * Signed and dated informed consent form * Willingness to comply with study protocol and availability for the duration of the study
Exclusion criteria
* Diagnosis of moccasin-type tinea pedis * Presence of serous exudate or pus * Treatment with a topical antifungal in the past 2 weeks * Treatment with a systemic antifungal in the past 4 weeks * Concurrent immunosuppressive or antimicrobial therapy * Liver disease * Pregnancy or breastfeeding * Use any other antifungal therapy during trial or within three months of starting the trial * Known hypersensitivity to any ingredients of trial agents * Patients with a current diagnosis of diabetes or neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects with a Complete Cure at Week 4 | Week 4 | Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4. |
Countries
United States
Contacts
Primary ContactPrinicipal Investigator
Outcome results
None listed