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This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.
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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 |
|---|---|---|
| Success rate of Investigator's Global Assessment (IGA) | % of patients with IGA score of 0 (clear) or 1 (almost clear) | 4 weeks |
| Blood concentrations of PAC-14028 | Blood concentrations of PAC-14028 | Day 1, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of IGA (Investigator's Global Assessment) | Change of IGA score from baseline | 1, 2, 4 week(s) |
| Change of SCORAD (Severity Scoring of Atopic Dermatitis) | Change of SCORAD from baseline |
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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 |
|---|---|---|---|---|---|---|
| Chung-ang University Hospital | Seoul | South Korea | ||||
| Konkuk University Hospital |
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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, 2, 4 week(s) |
| % Change of EASI (Eczema Area and Severity Index) | 1, 2, 4 week(s) |
| Patient satisfaction measurement | 4 weeks |
| Seoul |
| South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |