Clinical study on the efficacy and safety of the single point subcutaneous injection of usinumab on the radial side of the proximal phalanx in the treatment of nail psoriasis

A clinical research to evaluate the efficacy and safety of the single point subcutaneous injection of usinumab on the radial side of the proximal phalanx in the treatment of nail psoriasis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073744

Enrollment

Unknown

Registered

2023-07-20

Start date

2023-07-20

Completion date

Unknown

Last updated

2023-10-22

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

Conditions

nail psoriasis

Interventions

Metronidazole group:usinumab, injection

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Patients that are standardized diagnosed of psoriasis vulgaris by Chinese guidelines for the diagnosis and treatment of psoriasis (2018 full edition), and with psoriatic nail changes, who do not respond to or have contraindications or are intolerant to other systemic therapies such as cyclosporine, methotrexate (MTX), or PUVA (psoralen and ultraviolet A); 3. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Any diseases that may cause nail damage, such as Paronychia, fungal infection, lichen planus, nail malnutrition,etc.; 2. Have been treated with topical nail-part drugs and (or) traditional systemic drugs (such as Acitretin, MTX, cyclosporine, etc.) in the past six months; 3. Have been treated with biological agents; 4. Be administered with a live virus or bacteria vaccine within one month; 5. Pregnant and lactating women; 6. Suffering from infectious diseases such as tuberculosis, hepatitis, syphilis, AIDS, septicemia, etc. Suffering from malignant tumors, kidney failure, liver dysfunction, chronic inflammatory diseases (e.g. lupus erythematosus, scleroderma, dermatomyositis, vasculitis, inflammatory bowel disease, etc.) ; 7. Those who are allergic to any component of usinumab injection; 8. Those with mental abnormalities and unrealistic fantasies about treatment.

Design outcomes

Primary

Measure	Time frame
Nail Psoriasis Severity Index;The location and number of resident memory T cells and the changes of proinflammatory cytokines (IL-17A, IL-23, IL-12, IFN-?);	—

Secondary

Measure	Time frame
Nail psoriasis severity index (NAPSI) improvement percentage;Nail Assessment in Psoriasis and Psoriasis Arthritis-Quality of Life;Psoriasis area and severity index;	—

Countries

China

Contacts

Public ContactMa Han

The Fifth Affiliated Hospital, Sun Yat-sen University

drmahan@sina.com+86 131 2824 7946

Outcome results

None listed

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