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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 daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | AN2718 Cream SF Vehicle |
|
| B | Experimental | AN2718 Cream SF, 0.3% |
|
| C | Experimental | AN2718 Cream SF, 1% |
|
| D | Experimental | AN2718 Gel Vehicle |
|
| E | Experimental | AN2718 Gel, 1.5% |
|
| F | Experimental | AN2718 Gel, 2.5% |
|
| G | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN2718 | Other | AN2718 Cream SF Vehicle, Daily for up to 21 days |
| |
| AN2718 |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation Score (5-point scale) | Daily for 21 days |
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Inclusion Criteria:
Subjects must meet all of the following criteria for inclusion in the study.
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 |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D012967 | Sodium Dodecyl Sulfate |
| ID | Term |
|---|---|
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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AN2718 Gel, 5%
|
| H | Experimental | AN2718 Gel, 7.5% |
|
| I | Active Comparator | Sodium Lauryl Sulfate, 0.5% |
|
| Drug |
AN2718 Cream SF, 0.3%, Daily for up to 21 days |
|
| AN2718 | Drug | AN2718 Cream SF, 1%, Daily for up to 21 days |
|
| AN2718 | Other | AN2718 Gel Vehicle, Daily for up to 21 days |
|
| AN2718 | Drug | AN2718 Gel, 1.5%, Daily for up to 21 days |
|
| AN2718 | Drug | AN2718 Gel, 2.5%, Daily for up to 21 days |
|
| AN2718 | Drug | AN2718 Gel, 5%, Daily for up to 21 days |
|
| AN2718 | Drug | AN2718 Gel, 7.5%, Daily for up to 21 days |
|
| Sodium Lauryl Sulfate | Other | Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days |
|
|
| 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 |
| D000476 |
| Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |