Clinical trial NCT02733874: A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, single blind, positive controlled trials that assess the effectiveness, safety and cost-effectiveness analysis in patients with mild to moderate psoriasis vulgaris and compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment.

Objectives of Study：

1. Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety;
2. Compare the cost-effectiveness analysis of two treatment programs.


Eligibility 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 (Physician Global Assessment,PGA) greater than or equal to 2;
5. The observation of target lesions of minimum diameter greater than or equal to 2cm.

Exclusion Criteria:

1. Patients who have known or been doubted of being allergic to the composition of the drug;
2. Patients who were diagnosed as non-psoriasis vulgaris (such as erythrodermic type, pustular psoriasis, arthritis), and developing psoriasis vulgaris;
3. Patients who have illnesses in 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 assessment of efficacy, such as eczema, etc.;
5. Liver functions(such as Alanine aminotransferase, Aspartate transaminase) is 2 times greater than(or equal to) the upper limit of normal value, or renal functions (such as creatinine) is 1.5 times greater than(or equal to) the upper limit of normal value;
6. Patients with hypercalcemia whose serum calcium values exceed the upper limit of the normal value or patients who were suspected of having a disease of hypercalcemia;
7. Patients who are taking drugs that affect metabolism of calcium. Drugs that increase the serum calcium values: agents containing calcium, active vitamin D3 medication, injection, anabolic agents (ipriflavone preparations); Drugs that decrease the serum calcium values: calcitonin preparation, double phosphate ester compound preparation, sex hormone preparations).
8. Patients who were randomly divided into groups had received systemic biological treatment (listed or unlisted), such as: ustekinumab treatment accepted by patients after the past 12 weeks, infliximab, adalimumab treatment accepted by patients after the past 8 weeks, infliximab, etanercept treatment accepted by patients after the past 4 weeks accepted and so on;
9. Patients who have accepted non-abiotic systemic therapy that may have an effect on psoriasis, including but not limited to vitamin A preparations, cortical hormone, vitamin D analogs, immunosuppressant, compound glycyrrhizin, traditional Chinese medicine and so on after the past 4 weeks of random entry or test period.
10. Patients who have were accepted psoralen ultraviolet A(PUVA) treatment after the past 4 weeks of random entry or test period.
11. Patients who have accepted ultraviolet therapy or partial treatments of psoriasis drugs after the past 2 weeks of random entry or test period;
12. Patients who have used concomitant drugs recently in the past 2 weeks after random entry or plan to use concomitant drugs during test period, such as Beta blockers, anti malaria drugs, lithium preparations, etc.;
13. Patients who have accepted other clinical trials after the the last 4 weeks of random entry;
14. Patients who work outside for a long time with sun exposure may have an impact on the diagnosis and treatment of the disease.
15. Women of lactation, pregnancy and childbearing age who refuse to accept effective contraceptive measures.
16. Patients who have known or been suspected of non-compliance, such as alcoholism, drug dependence or mental illness, etc, and can not be suitable to the clinical trials judged by the investigators.

Primary outcomes:
measure: The improvement of psoriasis area and severity index scores(PASI scores)
timeFrame: At baseline, 2 weeks and 4 weeks after baseline.
measure: The overall evaluation of the researchers (Physician Global Assessment,PGA)
timeFrame: At baseline, 2 weeks and 4 weeks after baseline.
measure: The Symptom score reduce index (SSRI)
timeFrame: 4 weeks after baseline.
measure: Efficiency of treatment
timeFrame: 4 weeks after baseline.
Secondary outcomes:
measure: Healing rate
timeFrame: 4 weeks after treatment
measure: Markedly effective rate
timeFrame: 4 weeks after treatment
measure: Response rate of PASI (PASI 75) after the treatment of 4 weeks
timeFrame: 4 weeks after treatment
measure: Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks
timeFrame: 4 weeks after treatment
Other outcomes:
Locations:
Study officials:
References: