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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

1% Tolnaftate Stick Formula A
Drug
Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
1% Tolnaftate Stick Formula B
Drug
Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
1% Tolnaftate Stick Formula C
Drug
Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: Tolnaftate Stick Formula AExperimental treatment 1 intervention

Group B: Tolnaftate Stick Formula BExperimental treatment 1 intervention

Group C: Tolnaftate Stick Formula CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage of Subjects with a Complete Cure at Week 4

Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.

Time frame

Week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Propedix, Inc.

Lead sponsor

Source ClinicalTrials.gov

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