Not yet recruiting NCT07102888
A Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RSS0393 Ointment.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis in Children, Plaque Psoriasis in Adolescents. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
Overview
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
- Drug RSS0393 Ointment
RSS0393 ointment.
Primary outcome measures
- Adverse events (AEs). [Time frame: About 4 weeks.]
Secondary outcome measures (1)
- The trough concentration of RSS0393. [Time frame: About 4 weeks.]
Eligibility criteria
Inclusion criteria
- Age ≥ 6 years old and < 18 years old at screening.
- History of plaque psoriasis ≥ 3 months.
- The subjects and their parents or legal guardians voluntarily signed informed consent before any study-related procedures began.
Exclusion criteria
- Diagnosis of psoriasis other than plaque at screening.
- Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study.
- Subjects with any other persistent active autoimmune disease.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Children's Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07102888 · RSS0393Oint-203