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

Conditions

• Tinea Pedis

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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).

Key Dates

Start date

Dec 30, 2024

Status verified

Nov 2025

Primary completion

Feb 28, 2026

Completion

Feb 28, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Tolnaftate Stick Formula A
  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.
• Experimental: Tolnaftate Stick Formula B
  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.
• Experimental: Tolnaftate Stick Formula C
  Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.

Primary Outcome Measure

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

Central Contacts

• Prinicipal Investigator
  617-869-0126
  [email protected]

Locations (2)

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