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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the USA, Canada and Australia.
The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | W0027 |
|
| 2 | Experimental | W0027 |
|
| 3 | Experimental | W0027 |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| W0027 | Drug | capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives of this study are: To assess the safety and tolerability of three W0027 regimens in subjects with MTTP; To assess skin and nail pharmacokinetics of three Albaconazole doses in subjects with MTTP. | Skin and Plasma samples Week 0 (Visit 2) through to Week 8 (Visit 9), Nail samples Week 0 (Visit 2) Week 4(Visit 7) and Week 8(Visit 9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynda Spelman, MD | South East Dermatology, South East Dermatology, Carina QLD 4152, Australia | Principal Investigator |
| Michael Freeman, MD | The Skin Centre, Benowa QLD 4217, Australia | Principal Investigator |
| Peter Foley, MD | Skin and Cancer Foundation, Carlton VIC 3053 , Australia | Principal Investigator |
| Stephen Shumack, MD | St George Dermatology and Skin Cancer Centre, Kogarah NSW 2217, Australia | Principal Investigator |
| Warren Weightman, MD | Dermatology on Ward, North Adelaide SA 5006, Australia | Principal Investigator |
| Debra Breneman, MD | University Dermatology Consultants, Inc., Cincinnati, OH, 45219, US | Principal Investigator |
| Eduardo Tschen, MD | Albuquerque, NM 87106, US | Principal Investigator |
| Yves Poulin, MD | Centre de Dermatologie de Québec Métropolitain, Quebec, QC, G1V 4X7, Canada | Principal Investigator |
| David Gratton, MD | International Dermatology Research Inc., Montreal, QC, H3H 1V4, Canada |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States | ||
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| Drug |
Placebo |
|
| Principal Investigator |
| Wayne Gulliver Gulliver, MD | NewLab Clinical Research, St. John's, NF, A1B 3E1, Canada | Principal Investigator |
| Steven Grekin, MD | 13450 East 12 Mile Road, Warren, MI 48088, US | Principal Investigator |
| Joseph Fowler, MD | Dermatology Specialists, 501 South Second Street, Louisville, KY 40202, US | Principal Investigator |
| Warren |
| Michigan |
| 48088 |
| United States |
| Albuquerque | New Mexico | 87106 | United States |
| University Dermatology Consultants, Inc. | Cincinnati | Ohio | 45219 | United States |
| St George Dermatology and Skin Cancer Centre | Kogarah | New South Wales | NSW 2217 | Australia |
| The Skin Centre | Benowa | Queensland | QLD 4217 | Australia |
| South East Dermatology | Carina | Queensland | QLD 4152 | Australia |
| Dermatology on Ward | North Adelaide | South Australia | SA 5006 | Australia |
| Skin and Cancer Foundation | Carlton | Victoria | VIC 3053 | Australia |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
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