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The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAC-14028 cream 0.3% | Experimental | PAC-14028 cream 0.3%, twice daily for 28 days |
|
| PAC-14028 cream 1.0% | Experimental | PAC-14028 cream 1.0%, twice daily for 28days |
|
| Vehicle | Placebo Comparator | Vehicle, twice daily for 28days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC-14028 | Drug | Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale (VAS) | Patient reported outcome of pruritis measurement on a change in visual analog scale | Baseline through Study Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success rate | Baseline through Study Day 28 | |
| Change in specified symptom sum score (SRRC) Index | Baseline through Study Day 28 | |
| Change in transepidermal water loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Han Kim, MD,Ph.D | Department of Dermatology, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyu-Han Kim | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| C559614 | N-(1-(3,5-difluoro-4-methanesulfonylaminophenyl)ethyl)-3-(2-propyl-6-trifluoromethylpyridine-3-yl)acrylamide |
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| Vehicle | Other | Participants received topical Vehicle twice daily for 4 weeks |
|
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| Baseline through Study Day 28 |
| Change in skin hydration | Baseline through Study Day 28 |