Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UHE-103 Cream | Experimental | Subjects will apply at least a total of 4 grams* of the test article, covering both feet twice daily for 2 weeks |
|
| Naftin (naftifine hydrochloride) Cream, 2% | Active Comparator | Subjects will apply at least a total of 5 grams* of the test article, covering the interdigital areas of both feet and to the groin once daily for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UHE-103 Cream | Drug | UHE-103 is an investigational combinational therapy containing keratolytic and antifungal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Percentage of subjects with any local and systemic AEs defined as "possibly" or "probably" or "definitely" related by the investigator. | Baseline up to Day 16 |
| Local Skin Reactions (LSRs) | Percentage of subjects with presence of any of the following LSRs at the end of the study: burning/stinging, edema, and oozing/vesiculation/crusting. | Day 16 |
| AUC (0-12 hours) | Defined as the area concentration-time curve (AUC) of the active antifungal drug from time 0 to 12 hours. | Day 15 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tony Andrasfay | Therapeutics Inc. (CRO) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #1 | San Diego | California | 92123 | United States | ||
| Site #5 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Naftin (naftifine hydrochloride) Cream | Drug | Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug |
|
| Thousand Oaks |
| California |
| 91320 |
| United States |
| Site #2 | Austin | Texas | 78759 | United States |
| Site #3 | College Station | Texas | 77845 | United States |
| Site #4 | Houston | Texas | 77055 | United States |
| ID | Term |
|---|---|
| D000084002 | Tinea Cruris |
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D007402 | Intertrigo |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C029178 | naftifine |
Not provided
Not provided
Not provided