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An open, multi-center, observational study on the effectiveness and safety of Anjianning in the treatment of children and adolescents with plaque psoriasis in the real world setting

An open, multi-center, observational study on the effectiveness and safety of Anjianning in the treatment of children and adolescents with plaque psoriasis in the real world setting

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053012
Enrollment
Unknown
Registered
2021-11-08
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Aged 4 to 18 years; 2. Patients with severe psoriasis (the definition of severe psoriasis meets at least one of the following): (1) Physician's Global Assessment Index (PGA) >= 4; (2) Involved area > 20% body surface area (BSA), or involved area > 10% BSA combined with very thick skin lesions; (3) (Psoriasis Area and Severity Index) PASI > 20, or PASI > 10 combined with at least one of the following: (4) Active psoriatic arthritis does not respond to non-steroidal anti-inflammatory drugs; (5) Children's Dermatology Life Quality Index (CDLQI) > 10; (6) Clinically relevant facial, genital or hand and/or foot involvement; 3. Have not used biological agents before.

Exclusion criteria

Exclusion criteria: 1. Patients participating in other clinical trials; 2. Those who are in the period of systemic acute or chronic infection, or have a history of active tuberculosis or hepatitis in the past; 3. Malignant tumor subjects; 4. Patients with severe heart, liver, kidney and other organs and systemic diseases; 5. There are cases where other investigators consider it inappropriate to use the test drug.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with >=75% decrease in Psoriasis Area and Severity Index scores;

Secondary

MeasureTime frame
Proportion of patients with psoriasis area and severity index of 50/90;Physician's Global Assessment ;Body Surface Area;modified Body Mass Index ;

Countries

China

Contacts

Public ContactGao Xinghua

The First Affiliated Hospital of China Medical University

gaobarry@hotmail.com+86 13940152467

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026