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This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAC-14028 cream 0.3% | Experimental | Twice daily for 4 weeks |
|
| PAC-14028 cream 1.0% | Experimental | Twice daily for 4 weeks |
|
| PAC-14028 cream vehicle | Placebo Comparator | Twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC-14028 cream 0.3% | Drug | Topical application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success rate in IGE(Investigator's Global Evaluation) | Treatment success rate in IGE on 28th day from the baseline | Change from Baseline at Day 14 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erythema severity score | Change from baseline at Day 14 and 28 | |
| Change in Scale severity score | Change from baseline at Day 14 and 28 | Baseline, Day 14 and Day 28 |
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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 |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| PAC-14028 cream 1.0% |
| Drug |
Topical application |
|
| PAC-14028 cream vehicle | Drug | Topical application |
|
| Change in Visual Analogue Scale(VAS) score | Change from baseline at Day 14 and 28 |
| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |