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This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KR230109 cream 0.025% | Experimental | Participants applied KR230109 cream once daily for 12 consecutive weeks. |
|
| KR230109 cream 0.05% | Experimental | Participants applied KR230109 cream once daily for 12 consecutive weeks. |
|
| placebo | Placebo Comparator | Participants applied placebo once daily for 12 consecutive weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KR230109 cream 0.025% | Drug | KR230109 cream 0.025% is indicated for the topical treatment of acne vulgaris in patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change from baseline in the count of non-inflammatory facial lesions | The percentage change from baseline in the count of non-inflammatory facial lesions at Week 12 compared with placebo in each treatment group. | week 12 |
| The percentage change from baseline in the count of inflammatory facial lesions | The percentage change from baseline in the count of inflammatory facial lesions at Week 12 compared with placebo in each treatment group. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions | The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions at weeks 2, 4, 8 of treatment compared with placebo for each treatment group. | week 2,4,8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianzhong zhang, Master | Contact | +86 18001315877 | rmpkzc@163.com | |
| cheng zhou, Doctor | Contact | +86 18910291182 | rmzjz@126.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| KR230109 cream 0.05% | Drug | KR230109 cream 0.05% is indicated for the topical treatment of acne vulgaris in patients |
|
| Placebo | Drug | Vehicle cream manufactured to mimic look and feel of KR230109 Cream but without the active ingredient. |
|
|
| The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions |
The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions at weeks 2, 4, 8, 12 of treatment compared with placebo for each treatment group. |
| week 2,4,8,12 |
| The average percentage change and absolute change from baseline in the total skin lesion count | The average percentage change and absolute change from baseline in the total skin lesion count at weeks 2, 4, 8, 12 of treatment compared with placebo for each treatment group. | week 2,4,8,12 |
| The proportion of participants in each treatment group with at least a 2-point reduction in IGA score from baseline and an IGA score of 0 or 1 | The proportion of participants in each treatment group with at least a 2-point reduction in IGA score from baseline and an IGA score of 0 or 1 at weeks 2, 4, 8, 12 of treatment compared with placebo. | week 2,4,8,12 |
| Safety endpoints | Adverse events (AEs), local skin reactions (LSRs), physical examinations, vital signs, electrocardiograms (ECGs), and abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine). | from day 1 to week 12 |
| Steady-state PK parameters of KR230109: Cmax,ss. | Steady-state PK parameters of KR230109: Cmax,ss. | week 4 |
| Steady-state PK parameters of KR230109: AUC0-24h,ss, etc. | Steady-state PK parameters of KR230109: AUC0-24h,ss, etc. | weeks 4 |