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Post-Marketing Surveillance of Adverse Reactions in Psoriasis Patients Treated with Benvitimod Cream Based on Database Mining

Post-Marketing Surveillance of Adverse Reactions in Psoriasis Patients Treated with Benvitimod Cream Based on Database Mining

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118911
Enrollment
Unknown
Registered
2026-02-12
Start date
2025-02-10
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Psoriasis

Interventions

Observation Group (grouped according to the group using Benvitimod cream and the group using Benvitimod cream and other concurrent medications):None

Sponsors

Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of psoriasis: Firstly, all patient records clearly diagnosed with psoriasis by clinical doctors are screened out from the electronic medical record system. This usually involves keyword search (such as "psoriasis", "psoriasis vulgaris", etc.) and matching of diagnostic codes (such as the L40.* series in ICD-10) to ensure the diagnostic accuracy of the selected cases. 2. Use of benvitimod cream: Further, patients with records showing the use of benvitimod cream for treatment during or after diagnosis are screened out. This requires reviewing prescription records, medication usage logs or medical orders to confirm the actual application of benvitimod cream. 3. The study plans to include 1000 patient cases using the target medication (benvitimod cream), which will be stratified into two groups for analysis: a benvitimod cream monotherapy group and a combination therapy group receiving benvitimod cream with other concomitant medications.

Exclusion criteria

Exclusion criteria: 1. Exclude cases with unclear diagnosis or those later revised to other skin diseases to ensure the purity of the study population; 2. Exclude cases lacking key information such as treatment outcome feedback, adverse reaction records or important demographic data, as these data are crucial for subsequent analysis; 3. If a patient uses benvitimod cream while also receiving other special treatments that may affect the research results (such as using other potent immunomodulatory drugs at the same time), they should be considered for exclusion, unless the influence of these confounding factors can be controlled through stratified analysis or other statistical methods.

Design outcomes

Primary

MeasureTime frame
Safety indicators (including: adverse reactions, abnormal laboratory tests, changes in vital signs);

Countries

China

Contacts

Public ContactJiang Yong

Second Hospital of Tianjin Medical University

jy1313@sohu.com+86 136 1212 3611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026