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The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAC-14028 cream 1% | Experimental | PAC-14028 cream 1%, twice daily for 8 weeks |
|
| Rozex gel 0.75% | Active Comparator | Rozex gel 0.75%, twice daily for 8 weeks |
|
| Vehicle | Placebo Comparator | Vehicle, twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC-14028 cream 1% | Drug | Participants received topical PAC-14028 cream 1% twice daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Investigator Global Assessment (IGA) | Baseline through Study Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema severity | Baseline through Study Week 8 | |
| Telangiectasia severity | Baseline through Study Week 8 | |
| Inflammatory lesion counts |
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Inclusion Criteria:
Male and female patients at the age of 20 to 65 years old
Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to National Rosacea Committee Expert Society with
IGA score ≥ 2
Voluntarily signed written informed consent forms for study participation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BeomJoon Kim, Professor | Department of Dermatology, Chungang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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 8 weeks |
|
|
| Rozex gel 0.75% | Drug | Participants received topical Rozex gel 0.75% twice daily for 8 weeks |
|
| Baseline through Study Week 8 |