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The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Elidel cream 1% | Active Comparator | Elidel cream 1%, Twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC-14028 cream 1.0% | Drug | Topical application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SCORing Atopic Dermatitis (SCORAD) index | Change from baseline at Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) score | Change from baseline at Day 7, 14 and 28 | |
| Success rate to pruritus treatment | Change from baseline at Day 7, 14 and 28 | |
| Eczema Area and Severity Index (EASI) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BeomJoon Kim, Professor | Department of Dermatology, Chungang University Hospital | Principal Investigator |
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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 |
|
| Elidel cream 1% | Drug | Topical application |
|
| Change from baseline at Day 7, 14 and 28 |
| Each SCORAD index | Change from baseline at Day 7, 14 and 28 |
| Transepidermal Water Loss (TEWL) level | Change from baseline at Day 7, 14 and 28 |
| Skin Hydration level | Skin hydration was measured using the Corneometer | Change from baseline at Day 7, 14 and 28 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |