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| ID | Type | Description | Link |
|---|---|---|---|
| C3371011 | Other Identifier | Alias Study Number |
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The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | AN2690 Solution, 2.5% |
|
| B | Experimental | AN2690 Solution, 7.5% |
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| C | Experimental | AN2690 Solution, 5.0% |
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| D | Active Comparator | AN2690 Solution, Vehicle |
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| E | Active Comparator | Sodium Lauryl Sulfate, 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN2690 | Drug | AN2690 Solution, 2.5%, Daily for up to 21 days |
| |
| AN2690 |
| Measure | Description | Time Frame |
|---|---|---|
| Severe irritation (Grade 3 or 4) observed at any site | Daily for 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Education and Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C512998 | tavaborole |
| D012967 | Sodium Dodecyl Sulfate |
| ID | Term |
|---|---|
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
AN2690 Solution, 7.5%, Daily for up to 21 days |
|
| AN2690 | Drug | AN2690 Solution, 5.0%, Daily for up to 21 days |
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| AN2690 Solution, Vehicle | Other | AN2690 Solution, Vehicle, Daily for up to 21 days |
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| Sodium Lauryl Sulfate, 0.5% | Other | Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days |
|
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000476 |
| Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |