Atopic Dermatitis of Adults
Conditions
Brief summary
This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis
Interventions
DRUGRSS0393 ointment
RSS0393 ointment 0.05%
Sponsors
Reistone Biopharma Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old and ≤75 years old at screening. 2. History of atopic dermatitis ≥ 6 months. 3. BSA is between 3% and 20% (inclusive) and EASI score is ≥ 5 and vIGA-AD is 2 or 3. 4. The subjects signed informed consent before any study-related procedures began.
Exclusion criteria
1. Diagnosis of other dermatologic diseases at screening. 2. Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study. 3. Subjects with any other persistent active autoimmune disease. 4. Subjects who have received topical medication for psoriasis within 14 days before baseline, or systemic medication or phototherapy for psoriasis within 28 days before baseline, or biological agents for psoriasis within a specified time before baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with vIGA-AD success | Baseline, week 4 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75) | Up to 8 weeks | 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). |
| Percentage of subjects with vIGA-AD of "clear" or "almost clear" | Up to 8 weeks | 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). |
| The change of WI-NRS | Up to 8 weeks | 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. |
| Safety: treatment emergence adverse events | Up to 8 weeks | — |
Countries
China
Outcome results
None listed