Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045, China
Not Yet Recruiting
NCT Number: NCT07102888
A Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
6 year–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
RSS0393 Ointment
DrugRSS0393 ointment.
Primary outcomes
-
Adverse events (AEs).
Time frame: About 4 weeks.
Secondary outcomes
-
The trough concentration of RSS0393.
Time frame: About 4 weeks.
Study contacts
Contact information is provided by the study sponsor or research team.
Luyao Dong
CONTACT
Xiaoyan Bai
CONTACT
Sponsors and collaborators
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Industry
Registry information
Official study title
A Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 5, 2025
- Registry last updated
- Aug 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.