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This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.
PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAC-14028 cream 0.1% | Experimental | PAC-14028 cream 0.1%, Twice daily for 8 weeks |
|
| PAC-14028 cream 0.3% | Experimental | PAC-14028 cream 0.3%, Twice daily for 8 weeks |
|
| PAC-14028 cream 1.0% | Experimental | PAC-14028 cream 1.0%, Twice daily for 8 weeks |
|
| PAC-14028 cream vehicle | Placebo Comparator | PAC-14028 cream vehicle, Twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC-14028 cream 0.1% | Drug | Topical application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of Investigator's Global Assessment (IGA) | percent of patients with IGA score of 0 (clear) or 1 (almost clear) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of Investigator's Global Assessment (IGA) | percent of patients with IGA score of 0 (clear) or 1 (almost clear) | 1, 3, 6 week(s) |
| Change in SCORAD (Severity Score of Atopic Dermatitis) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beomjoon Kim, MD, PhD | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-ang University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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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 |
|
| 1, 3, 6, 8 week(s) |
| % Change in Eczema Area and Severity Index (EASI) | 1, 3, 6, 8 week(s) |
| Success rate of Pruritus Severity score | 1, 3, 6, 8 week(s) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |