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This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.
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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 Investigator Global Assessment (IGA) | Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline. | Week 4 from the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate in Investigator Global Assessment (IGA) | Week 4 from the baseline | |
| Change in the erythema severity score | Week 4 from the baseline | |
| Rate of change in inflammatory lesion counts |
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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 |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan-si | Gyeonggi-do | 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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| PAC-14028 cream 0.3% |
| Drug |
Topical application |
|
| PAC-14028 cream 1.0% | Drug | Topical application |
|
| PAC-14028 cream vehicle | Drug | Topical application |
|
| Week 4 from the baseline |
| Change in erythema index | Week 4 from the baseline |
| Change in the telangiectasia severity score | Week 4 from the baseline |