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The objective of this phase 2 study is to evaluate the safety and efficacy of HL-009 Liposomal Gel in adult patients with mild to moderate atopic dermatitis (AD).
This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with mild to moderate AD. Following a 2-week screening period, subjects will be randomly assigned into one of four treatment arms. Placebo or HL-009 study treatments will be administrated to subjects twice daily for 8 consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their respective trial sites at Weeks 0.5, 1, 2, 4, 6, 8, and 10 (Visits 3, 4, 5, 6, 7, 8, and 9). All study drugs will be in identical laminated tubes to preserve double-blinding of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-009 Liposomal Gel (0.07%) | Experimental | Administer topically twice a day for 8 consecutive weeks. |
|
| HL-009 Liposomal Gel (0.15%) | Experimental | Administer topically twice a day for 8 consecutive weeks. |
|
| HL-009 Liposomal Gel (0.30%) | Experimental | Administer topically twice a day for 8 consecutive weeks. |
|
| HL-009 Liposomal Gel (Placebo) | Placebo Comparator | Administer topically twice a day for 8 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-009 Liposomal Gel | Drug | Topical adenosylcobalamin gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score change from baseline on IGA at Week 8 | Weeks 0, 1, 2, 4, 6, and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who have a minimum of 2-point improvement in IGA score at Week 8 | Weeks 0, 1, 2, 4, 6, and 8 | |
| Score change from baseline on EASI at Week 8 | Weeks 0, 1, 2, 4, 6, and 8 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arlington Heights | Illinois | 60025 | United States | |||
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| Placebo | Drug | Placebo gel |
|
| Score change from baseline on VAS for pruritus at Week 8 |
| Weeks 0, 1, 2, 4, 6, and 8 |
| Score change from baseline on DLQI at Week 8 | Weeks 0, 1, 2, 4, 6, and 8 |
| Score change from baseline on SF-36 questionnaires at Week 8 | Weeks 0, 4, and 8 |
| Fridley |
| Minnesota |
| 55432 |
| United States |
| Berlin | New Jersey | 08009 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| South Euclid | Ohio | 44118 | United States |
| Portland | Oregon | 97223 | United States |
| Austin | Texas | 78759 | United States |