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This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.
PAC-14028 cream 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 1.0% | Experimental | PAC-14028 cream 1.0% will be applied to treatment area twice daily for 8 weeks. |
|
| PAC-14028 cream Vehicle | Placebo Comparator | PAC-14028 cream Vehicle will be applied to treatment area twice daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC-14028 cream 1.0% | 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 |
|---|---|---|
| Change of Investigator's Global Assessment (IGA) score | Change of IGA score from baseline | 8 weeks |
| Success rate of ≥2-grade Investigator's Global Assessment (IGA) | percent of patients with ≥2 grade reduction of IGA score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyuhan Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National 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 Vehicle |
| Drug |
topical application |
|
| 8 weeks |
| Percent of change in Eczema Area and Severity Index (EASI) | 8 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |