Plaque Psoriasis in Adolescents, Plaque Psoriasis in Children
Conditions
Brief summary
This study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of RSS0393 topical ointment in the treatment of plaque psoriasis in children and adolescents.
Interventions
DRUGRSS0393 Ointment
RSS0393 ointment.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 6 years old and \< 18 years old at screening. 2. History of plaque psoriasis ≥ 3 months. 3. The subjects and their parents or legal guardians voluntarily signed informed consent before any study-related procedures began.
Exclusion criteria
1. Diagnosis of psoriasis other than plaque 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 |
|---|---|
| Adverse events (AEs). | About 4 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| The trough concentration of RSS0393. | About 4 weeks. |
Countries
China
Contacts
Primary ContactXiaoyan Bai
Backup ContactLuyao Dong
Outcome results
None listed