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This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition.
The study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M518101 will be compared with positive, negative control and M518101 vehicle. The study duration is 21days and there will be at least 23 visits to study center including screening visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M518101 | Experimental | M518101 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks |
|
| M518101 Vehicle | Placebo Comparator | M518101 vehicle is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks |
|
| sodium lauryl sulfate | Active Comparator | A solution of 0.2% sodium lauryl sulfate is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control. |
|
| Saline | Sham Comparator | A solution of 0.9% saline is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M518101 | Drug |
| ||
| M518101 Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory skin responses | Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects. | 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 |