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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Plaque Psoriasis in Children Plaque Psoriasis in Adolescents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RSS0393 Ointment Group

Group Type EXPERIMENTAL

RSS0393 Ointment

Intervention Type DRUG

RSS0393 ointment.

Interventions

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RSS0393 Ointment

RSS0393 ointment.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No