A Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis

Not Applicable

Not yet recruiting

• Conditions: Plaque Psoriasis in Children; Plaque Psoriasis in Adolescents
• Interventions: Drug: RSS0393 Ointment

• Registration Number: NCT07102888
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study Start: 2025-08-01
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RSS0393 Ointment Group	RSS0393 Ointment	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs).	About 4 weeks.

Secondary Outcome Measures

Name	Time	Method
The trough concentration of RSS0393.	About 4 weeks.

Trial Locations

Locations (1)

Beijing Children's Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China