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Recruiting NCT07245667

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

Phase II Interventional Tinea Pedis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 1% Tolnaftate Stick Formula A, 1% Tolnaftate Stick Formula B, 1% Tolnaftate Stick Formula C.
Who it may be relevant to
Registry conditions: Tinea Pedis. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis

Overview

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

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

Primary outcome measures

  • Percentage of Subjects with a Complete Cure at Week 4 [Time frame: Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Kuchnir Dermatology and Dermatological Surgery — Framingham
  • Kuchnir Dermatology and Dermatological Surgery — Milford

Identifiers

NCT: NCT07245667 · PRO-TP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗