Multicentre, randomised, double-blind, placebo controlled trial on topically applied benvitimod cream in patients with psoriasis

• Register: ChiCTR
• Last refreshed on: 28 April 2013
• Main ID: ChiCTR-TRC-11001391
• Date of registration: 2011-06-27
• Primary sponsor: People's Hospital of Peking University
• Public title: Multicentre, randomised, double-blind, placebo controlled trial on topically applied benvitimod cream in patients with psoriasis
• Scientific title: Multicentre, randomised, double-blind, placebo controlled trial on topically applied benvitimod cream in patients with psoriasis
• Date of first enrolment: 2011-02-01
• Target sample size: Group A:120;Group B:120;Group C:120;
• Recruitment status: Completed
• URL: http://www.chictr.org/en/proj/show.aspx?proj=15
• Study type: Interventional
• Study design: Randomized parallel control

Countries of recruitment

China

Contacts

• Name: Zhang jian-zhong

• Name: Zhang jian-zhong

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male and female patients with Plaque Psoriasis aged 18 to 65 years, inclusive
2. In good general health and free of any disease state or physical condition that might impair evaluation of plaque psoriasis.
3. 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)
4. Have a minimum of 1 plaque that is at least 2 ? 2cm in size
5. WOCBP using and willing to continue to use adequate contraceptive precautions for the duration of the study
6. Willing and able to comply with the protocol and attend all study visits.
7. Provide written informed consent prior to the initiation of any study-related procedures.
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. History of neurological/psychiatric disorders, including psychotic disorders or dementia, or any other reason that would interfere with the patient’s participation in the trial;
3. Pregnancy or lactation;
4. Known or suspected hypersensitivity to any of the constituents of the investigational product;
5. Treatment with other investigational drug within 3 months of day 0 or current participation in another clinical trial;
6. Spontaneously improving or rapidly deteriorating plaque psoriasis;
7. Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk;
8. Pustular, erythrodermic, or other non-plaque forms of psoriasis;
9. Guttate psoriasis as the dominant form of psoriasis;
10. Use of any psoriasis vaccine or previous participation in an investigational study of any psoriasis vaccine within 36 weeks prior to the baseline visit;
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 4 weeks prior to the baseline visit;
13. Prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation within 4 weeks prior to the baseline visit;
14. Topical anti-psoriatic therapy (including topical retinoids and vitamin D analogs) on the areas to be treated within 2 weeks prior to the baseline visit;
15. Alcohol abuse.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Plaque psoriasis

Intervention(s)

Group A:0.5% Benvitimod cream;Group B:1.0% Benvitimod cream;Group C:Placebo;

Primary Outcome(s)

PGA;PASI;

Secondary Outcome(s)

Photographs of Target Plaques;

Source(s) of Monetary Support

Celestial Pharmaceutical (Shenzhen) co.,Ltd.

Secondary Sponsor(s)

Celestial Pharmaceutical(Shenzhen) co.,Ltd., Room 502A, Wuzi building, No.3092, Renminbei Road, Luohu District, Shenzhen, Guangdong, China