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A multi-center, randomized, single blind, positive controlled trials that assess the effect, safety and cost in patients with mild to moderate psoriasis vulgaris and compare Fufangbingsuanlvbeitasuo (Jinniuer) ointment to Gaibosanchunbeitamisong (Defubao) ointment

A multi-center, randomized, single blind, positive controlled trials that assess the effect, safety and cost in patients with mild to moderate psoriasis vulgaris and compare Fufangbingsuanlvbeitasuo (Jinniuer) ointment to Gaibosanchunbeitamisong (Defubao) ointment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008126
Enrollment
Unknown
Registered
2016-03-21
Start date
2015-06-24
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

Mild to moderate psoriasis

Interventions

test group:Compound Clobetasol Propionate Ointment group, 2 times a day, continuous treatment for 4 weeks, the local external use for psoriasis
control group:Calcipotriol Betamethasone Ointment group, 1 times a day, for 4 consecutive weeks. The local external for psoriasis.

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) The informed consent has been signed in; 2) Patients who were 18~65 years of age, stable psoriasis patients, the gender is not limited; 3) The lesion area does not exceed 10% of the total surface area of the body; 4) The overall evaluation of the researchers (PGA) = 2; 5) The observation of target lesions of minimum diameter greater than or equal to 2cm.

Exclusion criteria

Exclusion criteria: 1) Patiens who were suspected of being allergic to the composition of the drug; 2) Patiens who were diagnosed as non psoriasis vulgaris (such as erythrodermic type, pustular psoriasis, arthritis), and psoriasis; 3) There are severe central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system and mental disorders; 4) Patients with other diseases may affect the efficacy of the judge: such as eczema, etc.; 5) Liver function (ALT, AST) is more than 2 times the upper limit of normal, or renal function (Cr) is more than 1.5 times the upper limit of normal value; 6) Hypercalcemia serum calcium values exceed the upper limit of the normal value of patients), or have the possibility of disease caused by hypercalcemia; 7) Patiens who are taking affect calcium metabolism of drugs (the serum calcium values increased drug: containing calcium preparation, medication in the active form of vitamin D3, injection, anabolic agents (ipriflavone preparations); the serum calcium values to lower drug: calcitonin preparation, double phosphate ester compound preparation, sex hormone preparations) patients. 8) Patiens who were randomly divided into group had received systemic biological treatment (listed or unlisted), such as: within 12 weeks ago receive ustekinumab, within 8 weeks ago received infliximab, adalimumab, within 4 weeks ago received etanercept and so on; 9) Patiens who were randomly divided into groups of 4 weeks or test accepted abiotic systemic therapy may have an effect on psoriasis persons, including, but not limited to vitamin A preparations, cortical hormone, vitamin D analogs, immunosuppressant, compound glycyrrhizin, traditional Chinese medicine and so on. 10) Patients who were randomly enrolled received PUVA treatment within weeks of the first 4 weeks of the trial or randomly assigned to a group of 11 weeks before or during the study period received ultraviolet therapy, topical treatment of psoriasis drugs; 11) Patiens who were randomly divided into groups of 2 weeks worked or research plan during the use of psoriasis with drugs, such as: beta blockers, antimalarial drugs, lithium preparations, and so on; 12) Patiens who were randomly assigned to participate in other clinical trials in the first 13 weeks; 13) Patiens who acceptd for a long time in outdoor work to accept the sun, may have an impact on the diagnosis and treatment of this disease; 14) Lactation, pregnancy, and not to take effective contraceptive measures of women of childbearing age; 15) People who are known or suspected poor compliance can not be completed, such as alcoholism, drug dependence or mental illness, etc., the researchers are not suitable to participate in the clinical investigator.

Design outcomes

Primary

MeasureTime frame
Efficiency of treatment;

Secondary

MeasureTime frame
Cure rate, effective rate, curative effect composition, SSRI improvement rate, treatment 4 weeks PASI response rate (PASI 75), treatment 4 weeks PGA response rate (PGA basic regression rate);routine blood test;Urine routine;blood biochemical indeces;

Countries

China

Contacts

Public ContactXing-hua Gao

1st affiliated hospital of China medical university

gaobarry@hotmail.com+86 13940152467

Outcome results

None listed

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