Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study

Propedix, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: 1% Tolnaftate Stick Formula C; Drug: 1% Tolnaftate Stick Formula B; Drug: 1% Tolnaftate Stick Formula A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07245667

PRO-TP-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Tolnaftate Stick Formula A

Experimental group

Description:

Participants will receive Formula A, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.

Treatment:

Drug: 1% Tolnaftate Stick Formula A

Tolnaftate Stick Formula B

Experimental group

Description:

Participants will receive Formula B, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.

Treatment:

Drug: 1% Tolnaftate Stick Formula B

Tolnaftate Stick Formula C

Experimental group

Description:

Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.

Treatment:

Drug: 1% Tolnaftate Stick Formula C