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Multi-centre, randomised, double-blind, placebo- and comparator-controlled trial on topically applied benvitimod cream in patients with psoriasis

Multi-centre, randomised, double-blind, placebo- and comparator-controlled trial on topically applied benvitimod cream in patients with psoriasis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003259
Enrollment
Unknown
Registered
2013-04-07
Start date
2013-04-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Plaque psoriasis

Interventions

A:1.0% Benvitimod cream
C:Calcipotrione Ointment

Sponsors

People's Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male and female patients with plaque psoriasis aged 18 to 65 years; 2. A clinical diagnosis of stable plaque psoriasis representing a maximum of 10% of their total body surface area (excluding the face, groin, scalp, and genital regions); 3. Have a baseline PGA of >=2; 4. Have a minimum of one plaque that is at least 2*2cm in size; 5. In good general health and free of any disease state or physical condition that might impair evaluation of plaque psoriasis; 6. WOCBP using and willing to continue to use adequate contraceptive precautions for the duration of the study; 7. Willing and able to comply with the protocol and attend all study visits, provide written informed consent prior to the initiation of any study-related procedures.

Exclusion criteria

Exclusion criteria: 1. Other concomitant serious illness or medical condition (e.g., human immunodeficiency virus, renal insufficiency, clinically significant abnormal laboratory values) that could put a patient at risk during the study; 2. ALT or AST representing liver function is two times larger than the upper limit of normal value, or serum creatinine representing renal function, is higher than the upper limit of normal value; 3. The current diagnosis of non-plague form psoriasis (such as erythema, guttate and joint psoriasis), and progression of psoriasis vulgaris,drug-induced psoriasis vulgaris; skin lesions reach more than 10% of total body surface; 4. Palmoplantar psoriasis; 5. Pregnancy, lactation or who plan to be pregnant; 6. Known or suspected hypersensitivity to any of the constituents of the investigational product; 7. Treatment with other investigational drug within three months of day 0 or current participation in another clinical trial; 8. Alcohol dependent patients; 9. The frequent use of herb, sedatives, hypnotics, stabilizer and other addictive drugs; 10. Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk; 11. Systemic immunomodulatory therapy known to affect psoriasis and decreases immune cell populations (e.g., alefacept) within 36 weeks prior to the baseline visit; 12. Any phototherapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within four weeks prior to the baseline visit; 13. Topical anti-psoriatic therapy (including topical retinoids and vitamin D analogs) on the areas to be treated within two weeks prior to the baseline visit; 14.The subjects may not the study because of other reasons, or whose researchers think are unsuitable for this study;

Design outcomes

Primary

MeasureTime frame
PGA;Photographs of Target Plaques;PASI;

Countries

China

Contacts

Public ContactZhang jian-zhong
rmzjz@126.com+86 10 88325471

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026