Psoriasis
Conditions
Interventions
Test group :Initial treatment: Patients will apply Calcipotriol and Betamethasone Ointment once daily until they achieve PGA 0/1 then continue to apply once a day for another 4 weeks. Patients with st
Control group:Initial treatment: Patients will apply Calcipotriol and Betamethasone Ointment once daily until they achieve PGA 0/1 then continue to apply once a day for another 4 weeks. Patients with
Sponsors
Xijing Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Adult patients (= 18 years) • Meet the clinical diagnostic criteria for plaque psoriasis, and Physician’s Global Assessment (PGA) score of 2 (mild) to 4 (severe), and the skin lesions mainly involving the trunk and (or) limbs, and a percent of total body-surface area affected less than or equal to 10% • Patients, who are eligible for treatment with Daivobet® according to label • Patients, who are foreseen for treatment with Daivobet® and the decision to start treatment with Daivobet® was taken before enrolment in the study. • Patients, who have understood and voluntarily signed the ICF
Exclusion criteria
Exclusion criteria: •Patients who participated in any other interventional clinical trial within 30 days prior to the baseline visit. • Patients who have received any systemic treatment within 4 weeks or have received any topical treatment within 2 weeks before the baseline visit, or have received high-dose antibiotics within 1 week before the baseline visit. • Patients who cannot provide informed consent • Patients with severe cardiac, renal, hepatic, or systemic disease, cancer or immunodeficiency. • Pregnant women or women of childbearing age who are reluctant to use reliable contraception. • Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with PGA 0/1 at 26 weeks of treatment. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with PASI 75 after 26 weeks of treatment.;Percentage of patients with PASI 90 after 26 weeks of treatment;Changes in DLQI of patients compared to baseline at 26 weeks of treatment;Changes in SAS and SDS of patients compared to baseline at 26 weeks of treatment;Patients’ satisfaction after 26 weeks of treatment;Proportion of patients with no reported adverse events (AEs) during 26 weeks of treatment with calcipotriol betamethasone ointment ;Incidence of glucocorticoid-related adverse reactions at 26 weeks of treatment with calcipotriol and betamethasone ointment, as per physicians assessment.;Time to first relapse during maintenance treatment;Number of relapses during maintenance treatment within 26 weeks; | — |
Countries
China
Contacts
Public ContactWang Gang
Xijing Hospital of Air Force Military Medical University
Outcome results
None listed