Chronic Plaque Psoriasis, Obesity
Conditions
Brief summary
The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight reduction of at least 5%) could improve the response rate to a suboptimal dose of cyclosporine in patients with severe psoriasis.
Interventions
OTHERlow calorie diet
Low calorie diet was designed to achieve a loss of 5-10% of initial weight. All enrolled patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range 1200-1500 Kcal/day for women, 1300-1600 Kcal/day for men). Calorie intake consisted approximately of 60% carbohydrates, 25% fat, 15% protein
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age,active but clinically stable plaque psoriasis involving at least 10 percent of the body surface area and a psoriasis area and severity index (PASI) score ≥10 and a body mass index ≥30.
Exclusion criteria
* Other type of psoriasis (guttate, erythrodermic and pustular psoriasis) * Uncontrolled hypertension * Severe congestive heart failure * Renal and liver impairment * Active or chronic infections, including HIV, HBV and HCV infections, latent tuberculosis * Previous or active malignancies * Pregnancy and lactations * Previous treatment with cyclosporine * Phototherapy or any systemic or topical therapy for psoriasis within the previous 4 weeks before enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point PASI 75 response | week 24 |
Secondary
| Measure | Time frame |
|---|---|
| secondary end point was % of body weight reduction | week 24 |
Countries
Italy
Outcome results
None listed