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This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1: RSS0393 ointment 0.05% | Experimental |
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| Treatment group 2: RSS0393 ointment 0.01% | Experimental |
| |
| Treatment group 3: RSS0393 ointment 0.03% | Experimental |
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| Treatment group 4: RSS0393 ointment placebo | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS0393 ointment | Drug | RSS0393 ointment 0.05% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with vIGA-AD success | The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline | Baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75) | EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). | Up to 8 weeks |
| Percentage of subjects with vIGA-AD of "clear" or "almost clear" |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | 510091 | China |
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| RSS0393 ointment |
| Drug |
RSS0393 ointment 0.01% |
|
| RSS0393 ointment | Drug | RSS0393 ointment 0.03% |
|
| RSS0393 ointment | Drug | RSS0393 ointment placebo |
|
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). |
| Up to 8 weeks |
| The change of WI-NRS | The Worst Itch Numerical Rating Scale (WI-NRS) will be determined by the subject's recording of daily assessment of worst itch over the past 24 hours. | Up to 8 weeks |
| Safety: treatment emergence adverse events | Up to 8 weeks |