Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
ConditionTinea Pedis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorPropedix, Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 1% Tolnaftate Stick Formula A
- 1% Tolnaftate Stick Formula B
- 1% Tolnaftate Stick Formula C
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov