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This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q301 Cream | Experimental | Q301 Cream |
|
| Vehicle | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q301 Cream | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who have the IGA score of 0 or 1 | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline on the VAS for pruritus | Week 8 | |
| Percent change from baseline on the EASI | Week 8 | |
| Percent change from baseline on the SCORAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver | Colorado | 80220 | United States | |||
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|
| Week 8 |
| Percent change from baseline on the DLQI | Week 8 |
| Berlin |
| New Jersey |
| 08009 |
| United States |
| East Windsor | New Jersey | 08520 | United States |
| Buffalo | New York | 14203 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Austin | Texas | 78759 | United States |
| College Station | Texas | 77845 | United States |