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This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATx201 2% Gel | Experimental |
| |
| ATx201 4% Gel | Experimental |
| |
| ATx201 Gel Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATx201 | Drug | two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dermal Response Score | number of patients with a dermal response score of at least 2 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dermal Response and Effects Score | number of patients with a dermal response and effects score of at least 3 | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Prokocimer, MD | CMO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Clinical Applications, LLC | Springfield | Missouri | 65802 | United States |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ATx201 Placebo Gel | Drug | two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms |
|