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| Name | Class |
|---|---|
| TKL Research, Inc. | INDUSTRY |
| Accelovance | INDUSTRY |
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Purpose of this study will be to determine the potential of abametapir lotion to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abametapir Lotion 0.74% | Active Comparator | 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
|
| Vehicle Lotion | Placebo Comparator | 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
|
| 0.1% sodium lauryl sulfate | Other | Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
|
| Saline 0.9% | Other | Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abametapir Lotion 0.74% w/w | Drug |
| ||
| 0.1% sodium lauryl sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the sensitizing potential of abametapir lotion using repeat insult patch test design | Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Dosik | TKL Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Reserach | Paramus | New Jersey | 07652 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2021 | |
| Reset | Jun 9, 2021 | |
| Release | Jun 12, 2021 | |
| Reset | Jul 2, 2021 | |
| Release | Jul 3, 2021 | |
| Reset | Jul 23, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2021 | Jun 9, 2021 | |||
| Jun 12, 2021 |
| 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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| Other |
|
| saline 0.9% | Other |
|
| Vehicle Lotion | Other |
|
| Jul 2, 2021 |
| Jul 3, 2021 | Jul 23, 2021 |
| 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 |