Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:
• 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
Locations
United States
Massachusetts
Kuchnir Dermatology and Dermatological Surgery
RECRUITING
Framingham
Kuchnir Dermatology and Dermatological Surgery
RECRUITING
Milford
Contact Information
Primary
Prinicipal Investigator
cschanbacher@propedix.com
617-869-0126
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2026-02
Participants
Target number of participants: 150
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Propedix, Inc.