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The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAC-14028 cream 0.1% | Experimental | PAC-14028 cream 0.1%, Twice daily for 4 weeks |
|
| PAC-14028 cream 0.3% | Experimental | PAC-14028 cream 0.3%, Twice daily for 4 weeks |
|
| PAC-14028 cream 1.0% | Experimental | PAC-14028 cream 1.0%, Twice daily for 4 weeks |
|
| PAC-14028 cream vehicle | Placebo Comparator | PAC-14028 cream vehicle, Twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC-14028 cream 0.1% | Drug | Topical application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intensity of pruritus as measured by 10 cm VAS | Week 4 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success rate (A decrease in VAS by 2 or more is judged as a success) | Week 4 from baseline | |
| Change in Overall Dry Skin (ODS) score | Week 4 from baseline | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miyoung Park, PhD | Amorepacific R&D Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| PAC-14028 cream 0.3% |
| Drug |
Topical application |
|
| PAC-14028 cream 1.0% | Drug | Topical application |
|
| PAC-14028 cream vehicle | Drug | Topical application |
|
| Change in Transepidermal Water Loss (TEWL) |
| Week 4 from baseline |