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Efficacy and safety of an anti-human interleukin-8 murine monoclonal antibody cream in the treatment of scalp psoriasis: a multicenter, randomized, double-blind, placebo-controlled parallel study

Efficacy and safety of an anti-human interleukin-8 murine monoclonal antibody cream in the treatment of scalp psoriasis: a multicenter, randomized, double-blind, placebo-controlled parallel study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054119
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-13
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Scalp psoriasis

Interventions

treatment group:investigational product
control group:placebo

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. >=18 years old; 2. Clinically diagnosed as stable psoriasis vulgaris, which must be accompanied by head involvement; the area of scalp skin lesions is >= 10% of the head area; 3. Overall psoriasis area and severity score (PASI) <= 10 points; overall body surface area involved (BSA) <= 10%; 4. Non-head skin lesions<= 3% of the total body surface area; 5. Patients who have the capacity to voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to any component of the study drug; 2. Topical use of topical preparations that may affect the assessment of psoriasis (including but not limited to glucocorticoids, vitamin D3 derivatives, benvirade, calcineurin inhibitors, salicylic acid, coal tar) in the past 4 weeks; 3. Treatment with topical corticosteroids (except emollients and shampoos) within 2 weeks; 4. Guttate infection, patients with erythrodermic, pustular and joint psoriasis; or patients with other skin diseases that may interfere with the assessment of the disease; 5. Participated in other clinical investigators within 3 months before participating in this study; 6. Pregnant and lactating women, and women of childbearing age who are unwilling to take reliable contraceptive measures; 7. Combined with a history of serious diseases; 8. Laboratory test values meet any of the following criteria: serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), serum creatinine > 1.2 times ULN (for serum creatinine higher than 1.2 times ULN) The patients who have undergone a second re-examination, and those whose serum creatinine is still higher than 1.2 times the ULN after two consecutive tests are not eligible to participate in the study); 9. There are situations that may affect patient compliance, such as long-term business trips, drug addicts; 10. In addition to the above, the investigators judge that patients are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Scalp Psoriasis Severity Index Score;

Countries

China

Contacts

Public ContactGao Xinghua

The First Affiliated Hospital of China Medical University

wdy50588@163.com+86 15951086206

Outcome results

None listed

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