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This is a single center, randomized, controlled, within subject comparison, multiple dose study to determine the sensitization potential of M518101 on normal skin under occlusive patch condition.
During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M518101 | Experimental | M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
|
| M518101 Vehicle | Placebo Comparator | M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
|
| Sodium lauryl sulfate | Active Comparator | The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
|
| Saline | Sham Comparator | The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M518101 | Drug |
| ||
| M518101 Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory skin response score | Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules) | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL research | Fair Lawn | New Jersey | 07410 | United States |
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| ID | Term |
|---|---|
| D012967 | Sodium Dodecyl Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Sodium lauryl sulfate | Other |
|
| Saline | Other |
|
| D000476 |
| Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |