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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolnaftate Stick Formula A | Experimental | 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. |
|
| Tolnaftate Stick Formula B | Experimental | 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. |
|
| Tolnaftate Stick Formula C | Experimental | Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Tolnaftate Stick Formula A | Drug | Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prinicipal Investigator | Contact | 617-869-0126 | cschanbacher@propedix.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuchnir Dermatology and Dermatological Surgery | Recruiting | Framingham | Massachusetts | 01701 | United States |
Individual participant data (IPD) will not be shared outside the study team because this is a small study designed for internal evaluation of formulation performance and tolerability. Data will be presented only in aggregated, de-identified form in any publications or presentations.
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| 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. |
|
| Kuchnir Dermatology and Dermatological Surgery | Recruiting | Milford | Massachusetts | 01757 | United States |
|
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |